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ENDO: Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese

Sponsor
GI Dynamics (Industry)
Overall Status
Terminated
CT.gov ID
NCT01728116
Collaborator
(none)
325
Enrollment
25
Locations
2
Arms
38
Duration (Months)
13
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

Condition or Disease Intervention/Treatment Phase
  • Device: EndoBarrier
  • Procedure: Sham Procedure
 N/A

Detailed Description

This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.

Study Design

Study Type:
Interventional
Actual Enrollment :
325 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Device (EndoBarrier)

Device for glycemic control

Device: EndoBarrier
Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point
Other Names:
  • Duodenal-jejunal bypass liner (DJBL)

    		•
    Sham Comparator: Sham Procedure

    sham procedure

    Procedure: Sham Procedure
    Endoscopic evaluation but no device placement

    Outcome Measures

    Primary Outcome Measures

    1. Primary Efficacy Endpoint: Improvement in HbA1c [Baseline and12 months]

      Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation

    2. Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE [Baseline and 12 Months]

      Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.

    Secondary Outcome Measures

    1. Assessment of Total Cholesterol Change at 12 Months Compared to Baseline [Baseline and 12 Months]

    2. Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months [Baseline and 12 Months]

    3. LDL Change From Baseline [Baseline and 12 Months]

    4. Triglycerides Change From Baseline [Baseline and 12 Months]

    5. Fasting Glucose Change From Baseline [Baseline and 12 Months]

    6. Systolic BP Change From Baseline [Baseline and 12 Months]

    7. Diastolic BP Change From Baseline [Baseline and 12 Months]

    8. Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months [Baseline and 12 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males/females aged ≥ 21 years and ≤ 65 years

    • Diagnosis of Type 2 Diabetes for ≤ 20 years

    • Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)

    • Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i or TZD)

    • Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.

    • Subjects willing to comply with study requirements

    • Subjects who have signed an informed consent form

    Exclusion Criteria:

    • Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis

    • C-peptide < 1.0 ng/mL

    • Triglyceride level > 400 mg/dL

    • Vitamin D deficiency (<20 ng/mL)

    • Male subjects with serum Creatinine >1.5 mg/dl or female subjects with Creatinine >1.4 mg/dL

    • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy

    • Height < 5 feet (152.4 cm)

    • Current alcohol or drug addiction

    • Symptomatic kidney stones or gallstones within 6 months prior to randomization

    • Chronic pancreatitis or acute pancreatitis within 12 months of randomization

    • Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide

    • Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)

    • Active gastroesophageal reflux disease [GERD] uncontrolled with a Proton Pump Inhibitor (PPI)

    • Thyroid disease unless controlled with medication

    • Currently taking Non-Steroidal Anti-Inflammatory Drugs [NSAIDs] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure

    • Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure

    • Currently taking systemic corticosteroids, drugs known to affect GI motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure

    • Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or insulin) within 3 months of screening

    • Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers

    • Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics

    • Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)

    • Previous GI surgery or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier device, liner or affect the function of the liner

    • Abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization

    • Any condition or major illness that places the subject at undue risk by participating in the study

    • Poor dentition not allowing complete chewing of food

    • Enrolled in another investigational study within 3 months of screening for this study (Enrollment in observational studies is permitted)

    • Residing in a location without ready access to study site medical resources

    • Documented weight loss of >10 pounds anytime during the 3 months preceding randomization

    • Positive stool guaiac at time of screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    3 Little Rock Diagnostic Center (LRDC) Little Rock Arkansas United States 72205
    4 Cedars-Sinai Medical Center Los Angeles California United States 90048
    5 Stanford University School of Medicine Stanford California United States 94305
    6 University of Colorado/ Anschutz Health & Wellness Center Aurora Colorado United States 80045
    7 Emory University Atlanta Georgia United States 30303
    8 Northwestern University Chicago Illinois United States 60208
    9 Kentucky Research Group Louisville Kentucky United States 40218
    10 Tulane University Health Sciences Center New Orleans Louisiana United States 70112-2699
    11 MedStar Health Research Institute Hyattsville Maryland United States 20782
    12 Massachusetts General Hospital Boston Massachusetts United States 02114
    13 Boston Medical Center Boston Massachusetts United States 02118
    14 University of Michigan Ann Arbor Michigan United States 48109
    15 Mayo Clinic Minnesota Rochester Minnesota United States 55905
    16 Washington University St Louis Missouri United States 63110
    17 Billings Clinic Billings Montana United States 59101
    18 Beth Israel Medical Center New York New York United States 10003
    19 University of North Carolina Chapel Hill North Carolina United States 27599
    20 Cleveland Clinic Cleveland Ohio United States 44195
    21 Legacy Research Institute Portland Oregon United States 97232
    22 Endocrinology Consultants of East Tennessee & Gastrointestinal Associates Knoxville Tennessee United States 37909
    23 Dallas Diabetes Dallas Texas United States 75230
    24 UT Southwestern Medical Center Dallas Texas United States 75390-7170
    25 The Methodist Hospital Research Institute Houston Texas United States 77030

    Sponsors and Collaborators

    • GI Dynamics

    Investigators

    • Study Chair: Lee M Kaplan, MD, PhD, Massachusetts General Hospital
    • Study Director: Keith Gersin, MD, Carolinas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    GI Dynamics
    ClinicalTrials.gov Identifier:
    NCT01728116
    Other Study ID Numbers:
    • 09-1
    First Posted:
    Nov 16, 2012
    Last Update Posted:
    Feb 1, 2017
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GI Dynamics
    glycemic control, type 2 diabetes, device, obese
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    Participant Flow

    Recruitment Details Up to 500 subjects were planned to be randomized into either the EndoBarrier or the sham control arm at a 2:1 ratio, respectively. Due to early termination of the trial, only 325 subjects were randomized with 216 EndoBarrier subjects and 109 sham control subjects.
    Pre-assignment Detail The mITT population for the primary analyses includes 213 EndoBarrier subjects and 107 sham control subjects. The remaining five (5) subjects (n=3 randomized to device; n=2 randomized to sham) were deemed ineligible before an attempted device placement due to findings identified during the upper endoscopy.
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group. Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
    Period Title: Overall Study
    STARTED 213 107
    COMPLETED 52 60
    NOT COMPLETED 161 47

    Baseline Characteristics

    Arm/Group Title EndoBarrier Group Sham Control Group Total
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Total of all reporting groups
    Overall Participants 213 107 320
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.9
    (8.19)
    51.8
    (8.21)
    52.5
    (8.20)
    Gender (Count of Participants)
    Female
    127
    59.6%
    69
    64.5%
    196
    61.3%
    Male
    86
    40.4%
    38
    35.5%
    124
    38.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    19
    8.9%
    14
    13.1%
    33
    10.3%
    Not Hispanic or Latino
    194
    91.1%
    93
    86.9%
    287
    89.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (participants) [Number]
    American Indian or Alaska Native
    6
    2.8%
    3
    2.8%
    9
    2.8%
    Asian
    1
    0.5%
    1
    0.9%
    2
    0.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    44
    20.7%
    22
    20.6%
    66
    20.6%
    White
    165
    77.5%
    80
    74.8%
    245
    76.6%
    More than one race
    1
    0.5%
    1
    0.9%
    2
    0.6%
    Unknown or Not Reported
    1
    0.5%
    1
    0.9%
    2
    0.6%
    Baseline Weight (lbs) (lbs) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [lbs]
    245.0
    (47.46)
    245.6
    (44.20)
    245.2
    (46.32)
    Baseline BMI (kg/m2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m2]
    38.4
    (5.74)
    38.3
    (5.33)
    38.4
    (5.60)
    HbA1c (%) fasting bloodwork (percent) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percent]
    8.8
    (0.92)
    8.9
    (0.89)
    8.8
    (0.91)

    Outcome Measures

    1. Primary Outcome
    Title Primary Efficacy Endpoint: Improvement in HbA1c
    Description Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
    Time Frame Baseline and12 months

    Outcome Measure Data

    Analysis Population Description
    All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 213 107
    Mean (Standard Deviation) [Percentage of HbA1c]
    -1.07
    (1.5)
    -0.31
    (1.59)
    2. Primary Outcome
    Title Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
    Description Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT without Imputation
    Arm/Group Title EndoBarrier Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
    Measure Participants 161
    Number (95% Confidence Interval) [percentage of participants]
    11.8
    5.5%
    3. Secondary Outcome
    Title Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 135 61
    Mean (Standard Deviation) [mg/dL]
    -11.30
    (34.39)
    -4.16
    (47.14)
    4. Secondary Outcome
    Title Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 135 61
    Number [percentage of participants]
    34.81
    16.3%
    9.84
    9.2%
    5. Secondary Outcome
    Title LDL Change From Baseline
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 133 59
    Mean (Standard Deviation) [mg/dL]
    -10.76
    (31.42)
    -10.54
    (40.35)
    6. Secondary Outcome
    Title Triglycerides Change From Baseline
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 135 61
    Mean (Standard Deviation) [mg/dL]
    -41.50
    (105.76)
    2.26
    (96.04)
    7. Secondary Outcome
    Title Fasting Glucose Change From Baseline
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 135 61
    Mean (Standard Deviation) [mg/dL]
    -38.90
    (66.08)
    5.31
    (73.65)
    8. Secondary Outcome
    Title Systolic BP Change From Baseline
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 134 59
    Mean (Standard Deviation) [mmHg]
    -2.76
    (17.07)
    1.22
    (16.47)
    9. Secondary Outcome
    Title Diastolic BP Change From Baseline
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 134 59
    Mean (Standard Deviation) [mmHg]
    -2.02
    (9.91)
    1.51
    (11.19)
    10. Secondary Outcome
    Title Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
    Description
    Time Frame Baseline and 12 Months

    Outcome Measure Data

    Analysis Population Description
    mITT population without imputation
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    Measure Participants 135 60
    Number [percentage of participants]
    60.74
    28.5%
    20.00
    18.7%

    Adverse Events

    Time Frame 18 months for device subjects, 12 months for sham subjects
    Adverse Event Reporting Description The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
    Arm/Group Title EndoBarrier Group Sham Control Group
    Arm/Group Description Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
    All Cause Mortality
    EndoBarrier Group Sham Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    EndoBarrier Group Sham Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 53/212 (25%) 5/108 (4.6%)
    Blood and lymphatic system disorders
    Anemia 1/212 (0.5%) 1 0/108 (0%) 0
    Cardiac disorders
    Atrial fibrillation 1/212 (0.5%) 1 0/108 (0%) 0
    Atrioventricular block complete 1/212 (0.5%) 1 0/108 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 8/212 (3.8%) 9 1/108 (0.9%) 1
    Abdominal pain upper 1/212 (0.5%) 1 0/108 (0%) 0
    Esophageal rupture 1/212 (0.5%) 1 0/108 (0%) 0
    Gastrointestinal hemorrhage 8/212 (3.8%) 9 0/108 (0%) 0
    Intestinal perforation 1/212 (0.5%) 1 0/108 (0%) 0
    Nausea 1/212 (0.5%) 1 0/108 (0%) 0
    Pancreatitis 2/212 (0.9%) 2 0/108 (0%) 0
    Pancreatitis acute 2/212 (0.9%) 2 1/108 (0.9%) 1
    Vomiting 3/212 (1.4%) 3 0/108 (0%) 0
    Cholelithiasis 2/212 (0.9%) 2 0/108 (0%) 0
    General disorders
    Adhesion 1/212 (0.5%) 1 0/108 (0%) 0
    Chest Pain 1/212 (0.5%) 1 0/108 (0%) 0
    Complication of device removal 1/212 (0.5%) 1 0/108 (0%) 0
    Obstruction 4/212 (1.9%) 4 0/108 (0%) 0
    Pseudopolyp 1/212 (0.5%) 1 0/108 (0%) 0
    Hepatobiliary disorders
    Cholecystitis 4/212 (1.9%) 4 0/108 (0%) 0
    Cholecystitis acute 3/212 (1.4%) 3 0/108 (0%) 0
    Infections and infestations
    Abscess 1/212 (0.5%) 1 0/108 (0%) 0
    Appendicitis 1/212 (0.5%) 1 0/108 (0%) 0
    Cellulitis 1/212 (0.5%) 1 0/108 (0%) 0
    Emphysematous pyelonephritis 1/212 (0.5%) 1 0/108 (0%) 0
    Incision site cellulitis 1/212 (0.5%) 1 0/108 (0%) 0
    Liver abscess 7/212 (3.3%) 7 0/108 (0%) 0
    Pneumonia 3/212 (1.4%) 4 0/108 (0%) 0
    Scrotal infection 1/212 (0.5%) 1 0/108 (0%) 0
    Sepsis 1/212 (0.5%) 1 0/108 (0%) 0
    Staphylococcal bacteremia 1/212 (0.5%) 1 0/108 (0%) 0
    Urinary tract infection 0/212 (0%) 0 1/108 (0.9%) 1
    Injury, poisoning and procedural complications
    Esophageal injury 1/212 (0.5%) 1 0/108 (0%) 0
    Investigations
    Transaminases increased 1/212 (0.5%) 1 0/108 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/212 (0.5%) 1 0/108 (0%) 0
    Hyperglycemia 0/212 (0%) 0 1/108 (0.9%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid cancer 0/212 (0%) 0 1/108 (0.9%) 1
    Nervous system disorders
    Syncope 1/212 (0.5%) 1 0/108 (0%) 0
    Psychiatric disorders
    Mental status changes 1/212 (0.5%) 1 0/108 (0%) 0
    Suicidal ideation 1/212 (0.5%) 1 0/108 (0%) 0
    Renal and urinary disorders
    Renal failure acute 2/212 (0.9%) 2 0/108 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 1/212 (0.5%) 1 0/108 (0%) 0
    Pleural effusion 1/212 (0.5%) 1 0/108 (0%) 0
    Pneumothorax 1/212 (0.5%) 1 0/108 (0%) 0
    Surgical and medical procedures
    Cholecystectomy 1/212 (0.5%) 1 0/108 (0%) 0
    Other (Not Including Serious) Adverse Events
    EndoBarrier Group Sham Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 206/212 (97.2%) 96/108 (88.9%)
    Blood and lymphatic system disorders
    Anaemia 9/212 (4.2%) 10 3/108 (2.8%) 3
    Leukocytosis 1/212 (0.5%) 1 0/108 (0%) 0
    Lymphadenopathy 0/212 (0%) 0 1/108 (0.9%) 1
    Splenomegaly 3/212 (1.4%) 3 0/108 (0%) 0
    Cardiac disorders
    Atrioventricular block complete 1/212 (0.5%) 1 0/108 (0%) 0
    Coronary artery disease 1/212 (0.5%) 1 0/108 (0%) 0
    Palpitations 1/212 (0.5%) 1 1/108 (0.9%) 1
    Tachycardia 1/212 (0.5%) 1 0/108 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/212 (0%) 0 1/108 (0.9%) 1
    Hypoacusis 1/212 (0.5%) 1 0/108 (0%) 0
    Sudden hearing loss 0/212 (0%) 0 1/108 (0.9%) 1
    Vertigo 0/212 (0%) 0 1/108 (0.9%) 1
    Endocrine disorders
    Hypothyroidism 1/212 (0.5%) 1 0/108 (0%) 0
    Eye disorders
    Chalazion 1/212 (0.5%) 2 0/108 (0%) 0
    Conjunctivitis 1/212 (0.5%) 1 0/108 (0%) 0
    Corneal lesion 1/212 (0.5%) 1 0/108 (0%) 0
    Eye haemorrhage 1/212 (0.5%) 1 0/108 (0%) 0
    Eye swelling 0/212 (0%) 0 1/108 (0.9%) 1
    Keratitis 1/212 (0.5%) 1 0/108 (0%) 0
    Mydriasis 0/212 (0%) 0 1/108 (0.9%) 1
    Ocular hyperaemia 1/212 (0.5%) 1 0/108 (0%) 0
    Retinal haemorrhage 0/212 (0%) 0 1/108 (0.9%) 1
    Vision blurred 3/212 (1.4%) 3 1/108 (0.9%) 1
    Visual impairment 3/212 (1.4%) 3 1/108 (0.9%) 1
    Vitreous detachment 1/212 (0.5%) 1 0/108 (0%) 0
    Gastrointestinal disorders
    Abdominal adhesions 1/212 (0.5%) 1 0/108 (0%) 0
    Abdominal discomfort 75/212 (35.4%) 96 14/108 (13%) 17
    Abdominal distension 45/212 (21.2%) 55 13/108 (12%) 13
    Abdominal mass 1/212 (0.5%) 1 0/108 (0%) 0
    Abdominal pain 125/212 (59%) 223 22/108 (20.4%) 29
    Abdominal pain upper 7/212 (3.3%) 9 0/108 (0%) 0
    Abdominal rigidity 3/212 (1.4%) 3 0/108 (0%) 0
    Abdominal tenderness 2/212 (0.9%) 2 0/108 (0%) 0
    Abnormal faeces 7/212 (3.3%) 7 3/108 (2.8%) 4
    Barrett's oesophagus 2/212 (0.9%) 2 2/108 (1.9%) 2
    Bezoar 1/212 (0.5%) 1 0/108 (0%) 0
    Breath odour 1/212 (0.5%) 1 0/108 (0%) 0
    Cheilitis 1/212 (0.5%) 1 0/108 (0%) 0
    Constipation 57/212 (26.9%) 62 14/108 (13%) 16
    Diarrhoea 57/212 (26.9%) 74 39/108 (36.1%) 49
    Diverticulum 3/212 (1.4%) 3 0/108 (0%) 0
    Dry mouth 2/212 (0.9%) 2 1/108 (0.9%) 1
    Duodenal stenosis 1/212 (0.5%) 1 0/108 (0%) 0
    Duodenal ulcer 9/212 (4.2%) 9 0/108 (0%) 0
    Duodenitis 2/212 (0.9%) 2 0/108 (0%) 0
    Dyspepsia 1/212 (0.5%) 1 1/108 (0.9%) 1
    Enteritis 0/212 (0%) 0 1/108 (0.9%) 1
    Erosive oesophagitis 1/212 (0.5%) 1 0/108 (0%) 0
    Eructation 15/212 (7.1%) 17 3/108 (2.8%) 3
    Faecal incontinence 3/212 (1.4%) 3 1/108 (0.9%) 1
    Faeces discoloured 2/212 (0.9%) 2 0/108 (0%) 0
    Flatulence 29/212 (13.7%) 33 6/108 (5.6%) 6
    Frequent bowel movements 3/212 (1.4%) 3 2/108 (1.9%) 2
    Gastric polyps 1/212 (0.5%) 1 2/108 (1.9%) 2
    Gastric ulcer 1/212 (0.5%) 1 0/108 (0%) 0
    Gastritis 1/212 (0.5%) 1 0/108 (0%) 0
    Gastritis erosive 1/212 (0.5%) 1 0/108 (0%) 0
    Gastrointestinal haemorrhage 2/212 (0.9%) 4 0/108 (0%) 0
    Gastrointestinal inflammation 1/212 (0.5%) 1 0/108 (0%) 0
    Gastrooesophageal reflux disease 15/212 (7.1%) 18 9/108 (8.3%) 9
    Gingival pain 1/212 (0.5%) 1 0/108 (0%) 0
    Glossodynia 1/212 (0.5%) 1 0/108 (0%) 0
    Haematochezia 3/212 (1.4%) 3 2/108 (1.9%) 2
    Haemorrhoidal haemorrhage 1/212 (0.5%) 1 0/108 (0%) 0
    Haemorrhoids 4/212 (1.9%) 4 2/108 (1.9%) 2
    Hiatus hernia 1/212 (0.5%) 1 0/108 (0%) 0
    Impaired gastric emptying 0/212 (0%) 0 1/108 (0.9%) 1
    Infrequent bowel movements 1/212 (0.5%) 1 0/108 (0%) 0
    Irritable bowel syndrome 1/212 (0.5%) 1 0/108 (0%) 0
    Large intestine polyp 1/212 (0.5%) 1 0/108 (0%) 0
    Lip pain 1/212 (0.5%) 1 0/108 (0%) 0
    Lip swelling 4/212 (1.9%) 4 1/108 (0.9%) 1
    Nausea 111/212 (52.4%) 164 24/108 (22.2%) 27
    Odynophagia 1/212 (0.5%) 1 1/108 (0.9%) 1
    Oesophageal discomfort 1/212 (0.5%) 1 0/108 (0%) 0
    Oesophageal rupture 3/212 (1.4%) 5 0/108 (0%) 0
    Oesophageal ulcer 2/212 (0.9%) 3 0/108 (0%) 0
    Oesophagitis 0/212 (0%) 0 1/108 (0.9%) 1
    Oral pain 2/212 (0.9%) 2 0/108 (0%) 0
    Pancreatic mass 1/212 (0.5%) 1 0/108 (0%) 0
    Peptic ulcer 1/212 (0.5%) 1 0/108 (0%) 0
    Retching 2/212 (0.9%) 2 0/108 (0%) 0
    Stomatitis 1/212 (0.5%) 1 0/108 (0%) 0
    Tongue cyst 1/212 (0.5%) 1 0/108 (0%) 0
    Tooth loss 1/212 (0.5%) 1 0/108 (0%) 0
    Toothache 3/212 (1.4%) 3 1/108 (0.9%) 2
    Umbilical hernia 1/212 (0.5%) 1 0/108 (0%) 0
    Vomiting 68/212 (32.1%) 85 9/108 (8.3%) 9
    General disorders
    Adverse drug reaction 1/212 (0.5%) 1 1/108 (0.9%) 1
    Asthenia 7/212 (3.3%) 7 0/108 (0%) 0
    Chest discomfort 3/212 (1.4%) 3 0/108 (0%) 0
    Chest pain 3/212 (1.4%) 3 0/108 (0%) 0
    Chills 5/212 (2.4%) 5 1/108 (0.9%) 1
    Device dislocation 2/212 (0.9%) 2 0/108 (0%) 0
    Fatigue 27/212 (12.7%) 28 8/108 (7.4%) 9
    Feeling cold 1/212 (0.5%) 1 2/108 (1.9%) 2
    Feeling hot 1/212 (0.5%) 1 0/108 (0%) 0
    Feeling jittery 0/212 (0%) 0 1/108 (0.9%) 1
    Irritability 0/212 (0%) 0 1/108 (0.9%) 1
    Local swelling 1/212 (0.5%) 1 1/108 (0.9%) 1
    Obstruction 2/212 (0.9%) 2 0/108 (0%) 0
    Oedema mucosal 1/212 (0.5%) 1 0/108 (0%) 0
    Oedema peripheral 2/212 (0.9%) 2 3/108 (2.8%) 4
    Pseudopolyp 2/212 (0.9%) 2 0/108 (0%) 0
    Pyrexia 10/212 (4.7%) 13 4/108 (3.7%) 5
    Temperature intolerance 1/212 (0.5%) 1 0/108 (0%) 0
    Thirst 1/212 (0.5%) 1 0/108 (0%) 0
    Hepatobiliary disorders
    Biliary colic 2/212 (0.9%) 2 0/108 (0%) 0
    Biliary dilatation 1/212 (0.5%) 1 0/108 (0%) 0
    Biliary dyskinesia 1/212 (0.5%) 1 0/108 (0%) 0
    Cholecystitis 1/212 (0.5%) 1 0/108 (0%) 0
    Cholelithiasis 9/212 (4.2%) 9 1/108 (0.9%) 1
    Gallbladder polyp 1/212 (0.5%) 1 0/108 (0%) 0
    Hepatic cyst 2/212 (0.9%) 2 0/108 (0%) 0
    Hepatic lesion 2/212 (0.9%) 2 0/108 (0%) 0
    Hepatic steatosis 9/212 (4.2%) 9 1/108 (0.9%) 1
    Hepatomegaly 1/212 (0.5%) 1 0/108 (0%) 0
    Liver injury 1/212 (0.5%) 1 0/108 (0%) 0
    Immune system disorders
    Food allergy 0/212 (0%) 0 1/108 (0.9%) 1
    Hypersensitivity 1/212 (0.5%) 1 3/108 (2.8%) 3
    Multiple allergies 0/212 (0%) 0 1/108 (0.9%) 1
    Seasonal allergy 3/212 (1.4%) 3 2/108 (1.9%) 2
    Infections and infestations
    Acute sinusitis 0/212 (0%) 0 1/108 (0.9%) 1
    Bronchitis 3/212 (1.4%) 5 5/108 (4.6%) 7
    Carbuncle 0/212 (0%) 0 1/108 (0.9%) 1
    Cellulitis 1/212 (0.5%) 1 1/108 (0.9%) 1
    Cystitis 0/212 (0%) 0 1/108 (0.9%) 1
    Diverticulitis 2/212 (0.9%) 2 0/108 (0%) 0
    Ear infection 2/212 (0.9%) 2 2/108 (1.9%) 2
    Enterococcal bacteraemia 1/212 (0.5%) 1 0/108 (0%) 0
    Fungal infection 2/212 (0.9%) 2 1/108 (0.9%) 1
    Fungal skin infection 0/212 (0%) 0 1/108 (0.9%) 1
    Gastroenteritis 1/212 (0.5%) 1 0/108 (0%) 0
    Gastroenteritis norovirus 0/212 (0%) 0 1/108 (0.9%) 1
    Gastroenteritis viral 0/212 (0%) 0 2/108 (1.9%) 2
    Gastrointestinal viral infection 3/212 (1.4%) 3 2/108 (1.9%) 3
    Gingival infection 1/212 (0.5%) 3 0/108 (0%) 0
    Helicobacter infection 1/212 (0.5%) 1 0/108 (0%) 0
    Herpes zoster 3/212 (1.4%) 4 0/108 (0%) 0
    Infection 2/212 (0.9%) 2 0/108 (0%) 0
    Influenza 10/212 (4.7%) 10 5/108 (4.6%) 5
    Nasopharyngitis 20/212 (9.4%) 20 13/108 (12%) 16
    Pneumonia 6/212 (2.8%) 6 3/108 (2.8%) 3
    Respiratory tract infection 5/212 (2.4%) 5 0/108 (0%) 0
    Sialoadenitis 1/212 (0.5%) 1 1/108 (0.9%) 1
    Sinusitis 6/212 (2.8%) 8 5/108 (4.6%) 5
    Skin infection 1/212 (0.5%) 1 0/108 (0%) 0
    Tinea cruris 0/212 (0%) 0 1/108 (0.9%) 1
    Tooth abscess 2/212 (0.9%) 2 1/108 (0.9%) 1
    Tooth infection 2/212 (0.9%) 2 2/108 (1.9%) 2
    Trichomoniasis 0/212 (0%) 0 1/108 (0.9%) 1
    Upper respiratory tract infection 16/212 (7.5%) 17 7/108 (6.5%) 7
    Urinary tract infection 9/212 (4.2%) 10 2/108 (1.9%) 2
    Vaginitis bacterial 2/212 (0.9%) 2 1/108 (0.9%) 1
    Vulvovaginal candidiasis 1/212 (0.5%) 1 1/108 (0.9%) 2
    Vulvovaginal mycotic infection 3/212 (1.4%) 3 2/108 (1.9%) 4
    Injury, poisoning and procedural complications
    Ankle fracture 1/212 (0.5%) 1 0/108 (0%) 0
    Arthropod sting 0/212 (0%) 0 2/108 (1.9%) 2
    Contusion 3/212 (1.4%) 3 0/108 (0%) 0
    Excoriation 1/212 (0.5%) 1 1/108 (0.9%) 1
    Fall 1/212 (0.5%) 1 0/108 (0%) 0
    Foot fracture 1/212 (0.5%) 1 3/108 (2.8%) 3
    Humerus fracture 1/212 (0.5%) 1 0/108 (0%) 0
    Joint injury 0/212 (0%) 0 3/108 (2.8%) 4
    Laceration 2/212 (0.9%) 2 0/108 (0%) 0
    Ligament sprain 4/212 (1.9%) 4 0/108 (0%) 0
    Limb injury 1/212 (0.5%) 1 1/108 (0.9%) 1
    Lip injury 1/212 (0.5%) 1 0/108 (0%) 0
    Mouth injury 1/212 (0.5%) 1 0/108 (0%) 0
    Muscle strain 1/212 (0.5%) 1 1/108 (0.9%) 1
    Oesophageal injury 8/212 (3.8%) 8 0/108 (0%) 0
    Post-traumatic neck syndrome 1/212 (0.5%) 1 0/108 (0%) 0
    Post-traumatic pain 0/212 (0%) 0 1/108 (0.9%) 2
    Procedural pain 0/212 (0%) 0 1/108 (0.9%) 1
    Thermal burn 0/212 (0%) 0 1/108 (0.9%) 1
    Investigations
    Alanine aminotransferase increased 0/212 (0%) 0 1/108 (0.9%) 1
    Amylase decreased 3/212 (1.4%) 4 0/108 (0%) 0
    Blood albumin abnormal 0/212 (0%) 0 1/108 (0.9%) 1
    Blood alkaline phosphatase increased 5/212 (2.4%) 6 2/108 (1.9%) 2
    Blood bilirubin increased 1/212 (0.5%) 1 1/108 (0.9%) 1
    Blood calcium decreased 1/212 (0.5%) 1 0/108 (0%) 0
    Blood calcium increased 2/212 (0.9%) 2 1/108 (0.9%) 1
    Blood chloride decreased 3/212 (1.4%) 3 0/108 (0%) 0
    Blood cholesterol decreased 1/212 (0.5%) 1 0/108 (0%) 0
    Blood cholesterol increased 6/212 (2.8%) 6 2/108 (1.9%) 2
    Blood creatinine decreased 3/212 (1.4%) 4 0/108 (0%) 0
    Blood creatinine increased 1/212 (0.5%) 1 2/108 (1.9%) 2
    Blood electrolytes decreased 0/212 (0%) 0 1/108 (0.9%) 1
    Blood glucose increased 3/212 (1.4%) 3 2/108 (1.9%) 2
    Blood iron decreased 24/212 (11.3%) 27 9/108 (8.3%) 10
    Blood iron increased 1/212 (0.5%) 2 0/108 (0%) 0
    Blood magnesium decreased 9/212 (4.2%) 9 7/108 (6.5%) 7
    Blood potassium decreased 1/212 (0.5%) 1 0/108 (0%) 0
    Blood potassium increased 2/212 (0.9%) 2 1/108 (0.9%) 1
    Blood pressure increased 1/212 (0.5%) 1 0/108 (0%) 0
    Blood sodium decreased 4/212 (1.9%) 4 2/108 (1.9%) 2
    Blood triglycerides increased 5/212 (2.4%) 5 4/108 (3.7%) 4
    Blood urea increased 1/212 (0.5%) 1 3/108 (2.8%) 3
    Carbon dioxide decreased 1/212 (0.5%) 1 2/108 (1.9%) 2
    Electrocardiogram abnormal 1/212 (0.5%) 1 0/108 (0%) 0
    Glycosylated haemoglobin increased 8/212 (3.8%) 10 8/108 (7.4%) 9
    Haematocrit decreased 3/212 (1.4%) 4 3/108 (2.8%) 3
    Haematocrit increased 0/212 (0%) 0 1/108 (0.9%) 1
    Haemoglobin decreased 6/212 (2.8%) 7 1/108 (0.9%) 1
    Haemoglobin increased 2/212 (0.9%) 2 0/108 (0%) 0
    Hepatic enzyme increased 1/212 (0.5%) 2 0/108 (0%) 0
    High density lipoprotein decreased 2/212 (0.9%) 2 0/108 (0%) 0
    Insulin C-peptide increased 1/212 (0.5%) 1 0/108 (0%) 0
    Iron binding capacity total increased 4/212 (1.9%) 4 2/108 (1.9%) 2
    Laboratory test abnormal 1/212 (0.5%) 1 0/108 (0%) 0
    Lipase decreased 5/212 (2.4%) 5 1/108 (0.9%) 1
    Lipase increased 0/212 (0%) 0 1/108 (0.9%) 1
    Lipids increased 0/212 (0%) 0 1/108 (0.9%) 1
    Liver function test abnormal 1/212 (0.5%) 1 0/108 (0%) 0
    Low density lipoprotein decreased 1/212 (0.5%) 1 0/108 (0%) 0
    Low density lipoprotein increased 4/212 (1.9%) 4 1/108 (0.9%) 1
    Oxygen saturation decreased 2/212 (0.9%) 2 1/108 (0.9%) 1
    QRS axis abnormal 1/212 (0.5%) 1 0/108 (0%) 0
    Serum ferritin decreased 3/212 (1.4%) 5 1/108 (0.9%) 1
    Serum ferritin increased 1/212 (0.5%) 1 0/108 (0%) 0
    Transaminases increased 1/212 (0.5%) 1 1/108 (0.9%) 1
    Transferrin saturation decreased 21/212 (9.9%) 28 13/108 (12%) 16
    Transferrin saturation increased 1/212 (0.5%) 1 0/108 (0%) 0
    Vitamin B12 decreased 11/212 (5.2%) 13 1/108 (0.9%) 1
    Vitamin B12 increased 2/212 (0.9%) 2 1/108 (0.9%) 1
    Vitamin D decreased 14/212 (6.6%) 15 6/108 (5.6%) 6
    Hyperuricaemia 1/212 (0.5%) 1 0/108 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 3/212 (1.4%) 3 1/108 (0.9%) 1
    Dehydration 2/212 (0.9%) 2 1/108 (0.9%) 1
    Electrolyte imbalance 0/212 (0%) 0 1/108 (0.9%) 1
    Fluid overload 1/212 (0.5%) 1 0/108 (0%) 0
    Gout 3/212 (1.4%) 8 0/108 (0%) 0
    Hyperglycaemia 1/212 (0.5%) 1 0/108 (0%) 0
    Hypoglycaemia 36/212 (17%) 72 12/108 (11.1%) 33
    Hypokalaemia 2/212 (0.9%) 2 0/108 (0%) 0
    Hyponatraemia 1/212 (0.5%) 1 0/108 (0%) 0
    Increased appetite 1/212 (0.5%) 1 0/108 (0%) 0
    Iron deficiency 42/212 (19.8%) 45 14/108 (13%) 14
    Vitamin B12 deficiency 4/212 (1.9%) 4 1/108 (0.9%) 1
    Vitamin D deficiency 14/212 (6.6%) 14 12/108 (11.1%) 13
    Musculoskeletal and connective tissue disorders
    Arthralgia 10/212 (4.7%) 10 4/108 (3.7%) 5
    Back pain 45/212 (21.2%) 56 9/108 (8.3%) 9
    Bone loss 1/212 (0.5%) 1 0/108 (0%) 0
    Bursitis 1/212 (0.5%) 1 0/108 (0%) 0
    Fasciitis 1/212 (0.5%) 1 1/108 (0.9%) 1
    Flank pain 2/212 (0.9%) 2 0/108 (0%) 0
    Groin pain 1/212 (0.5%) 1 0/108 (0%) 0
    Joint stiffness 0/212 (0%) 0 1/108 (0.9%) 1
    Joint swelling 1/212 (0.5%) 1 0/108 (0%) 0
    Limb discomfort 2/212 (0.9%) 2 0/108 (0%) 0
    Monarthritis 0/212 (0%) 0 1/108 (0.9%) 1
    Muscle spasms 9/212 (4.2%) 9 4/108 (3.7%) 4
    Muscular weakness 0/212 (0%) 0 1/108 (0.9%) 1
    Musculoskeletal chest pain 2/212 (0.9%) 2 6/108 (5.6%) 6
    Musculoskeletal discomfort 1/212 (0.5%) 1 0/108 (0%) 0
    Musculoskeletal pain 2/212 (0.9%) 2 6/108 (5.6%) 6
    Musculoskeletal stiffness 1/212 (0.5%) 1 0/108 (0%) 0
    Myalgia 9/212 (4.2%) 10 5/108 (4.6%) 5
    Neck pain 4/212 (1.9%) 4 1/108 (0.9%) 1
    Pain in extremity 9/212 (4.2%) 11 4/108 (3.7%) 4
    Pain in jaw 1/212 (0.5%) 1 1/108 (0.9%) 1
    Tendonitis 3/212 (1.4%) 3 1/108 (0.9%) 1
    Tenosynovitis 0/212 (0%) 0 1/108 (0.9%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma 1/212 (0.5%) 1 0/108 (0%) 0
    Benign neoplasm of thyroid gland 1/212 (0.5%) 1 0/108 (0%) 0
    Breast cancer 1/212 (0.5%) 1 0/108 (0%) 0
    Renal cancer 1/212 (0.5%) 1 0/108 (0%) 0
    Nervous system disorders
    Carpal tunnel syndrome 1/212 (0.5%) 1 0/108 (0%) 0
    Diabetic neuropathy 2/212 (0.9%) 2 0/108 (0%) 0
    Disturbance in attention 1/212 (0.5%) 1 0/108 (0%) 0
    Dizziness 11/212 (5.2%) 12 3/108 (2.8%) 4
    Dizziness postural 0/212 (0%) 0 1/108 (0.9%) 1
    Dysgeusia 2/212 (0.9%) 2 0/108 (0%) 0
    Headache 24/212 (11.3%) 25 18/108 (16.7%) 23
    Hypoaesthesia 2/212 (0.9%) 3 1/108 (0.9%) 1
    Migraine with aura 1/212 (0.5%) 1 0/108 (0%) 0
    Neuropathy peripheral 1/212 (0.5%) 1 0/108 (0%) 0
    Paraesthesia 1/212 (0.5%) 2 0/108 (0%) 0
    Poor quality sleep 2/212 (0.9%) 2 0/108 (0%) 0
    Sciatic nerve neuropathy 1/212 (0.5%) 1 0/108 (0%) 0
    Sinus headache 1/212 (0.5%) 1 0/108 (0%) 0
    Syncope 3/212 (1.4%) 3 1/108 (0.9%) 1
    VIIth nerve paralysis 0/212 (0%) 0 1/108 (0.9%) 1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 1/212 (0.5%) 1 0/108 (0%) 0
    Psychiatric disorders
    Depression 6/212 (2.8%) 6 0/108 (0%) 0
    Insomnia 2/212 (0.9%) 2 0/108 (0%) 0
    Renal and urinary disorders
    Chromaturia 1/212 (0.5%) 1 1/108 (0.9%) 1
    Dysuria 2/212 (0.9%) 2 0/108 (0%) 0
    Micturition urgency 0/212 (0%) 0 1/108 (0.9%) 1
    Nephrolithiasis 1/212 (0.5%) 1 0/108 (0%) 0
    Pollakiuria 2/212 (0.9%) 2 0/108 (0%) 0
    Polyuria 0/212 (0%) 0 1/108 (0.9%) 1
    Renal cyst 2/212 (0.9%) 2 0/108 (0%) 0
    Renal mass 1/212 (0.5%) 1 0/108 (0%) 0
    Urinary retention 1/212 (0.5%) 1 0/108 (0%) 0
    Reproductive system and breast disorders
    Amenorrhoea 0/212 (0%) 0 1/108 (0.9%) 1
    Benign prostatic hyperplasia 0/212 (0%) 0 1/108 (0.9%) 1
    Breast cyst 1/212 (0.5%) 1 0/108 (0%) 0
    Breast mass 2/212 (0.9%) 2 0/108 (0%) 0
    Fallopian tube disorder 1/212 (0.5%) 1 0/108 (0%) 0
    Menopausal symptoms 1/212 (0.5%) 1 0/108 (0%) 0
    Prostatitis 0/212 (0%) 0 1/108 (0.9%) 1
    Scrotal mass 1/212 (0.5%) 1 0/108 (0%) 0
    Uterine haemorrhage 0/212 (0%) 0 1/108 (0.9%) 1
    Vulvovaginal pain 1/212 (0.5%) 1 0/108 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis 1/212 (0.5%) 1 0/108 (0%) 0
    Acute respiratory failure 1/212 (0.5%) 1 0/108 (0%) 0
    Asthma 2/212 (0.9%) 2 1/108 (0.9%) 2
    Cough 4/212 (1.9%) 4 4/108 (3.7%) 4
    Dysphonia 1/212 (0.5%) 1 0/108 (0%) 0
    Dyspnoea 2/212 (0.9%) 2 2/108 (1.9%) 2
    Hiccups 1/212 (0.5%) 1 0/108 (0%) 0
    Increased upper airway secretion 1/212 (0.5%) 1 0/108 (0%) 0
    Nasal congestion 1/212 (0.5%) 2 1/108 (0.9%) 1
    Oropharyngeal pain 40/212 (18.9%) 54 22/108 (20.4%) 25
    Pleuritic pain 2/212 (0.9%) 2 0/108 (0%) 0
    Pulmonary congestion 1/212 (0.5%) 1 0/108 (0%) 0
    Respiratory distress 1/212 (0.5%) 1 0/108 (0%) 0
    Respiratory tract congestion 0/212 (0%) 0 1/108 (0.9%) 1
    Rhinitis allergic 0/212 (0%) 0 1/108 (0.9%) 1
    Rhinorrhoea 1/212 (0.5%) 1 0/108 (0%) 0
    Sinus congestion 1/212 (0.5%) 1 2/108 (1.9%) 2
    Throat irritation 2/212 (0.9%) 2 1/108 (0.9%) 1
    Tonsillar inflammation 0/212 (0%) 0 1/108 (0.9%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 11/212 (5.2%) 11 0/108 (0%) 0
    Blister 0/212 (0%) 0 3/108 (2.8%) 3
    Dermal cyst 1/212 (0.5%) 1 0/108 (0%) 0
    Diabetic ulcer 0/212 (0%) 0 1/108 (0.9%) 1
    Dry skin 1/212 (0.5%) 1 0/108 (0%) 0
    Excessive granulation tissue 4/212 (1.9%) 4 0/108 (0%) 0
    Hyperhidrosis 3/212 (1.4%) 4 0/108 (0%) 0
    Ingrowing nail 1/212 (0.5%) 1 2/108 (1.9%) 2
    Night sweats 2/212 (0.9%) 2 1/108 (0.9%) 1
    Onychoclasis 1/212 (0.5%) 1 0/108 (0%) 0
    Pruritus 4/212 (1.9%) 4 1/108 (0.9%) 1
    Rash 4/212 (1.9%) 5 2/108 (1.9%) 2
    Rash erythematous 1/212 (0.5%) 1 0/108 (0%) 0
    Rosacea 0/212 (0%) 0 1/108 (0.9%) 1
    Skin discolouration 1/212 (0.5%) 1 0/108 (0%) 0
    Urticaria 0/212 (0%) 0 1/108 (0.9%) 1
    Surgical and medical procedures
    Artificial crown procedure 0/212 (0%) 0 1/108 (0.9%) 1
    Knee operation 0/212 (0%) 0 1/108 (0.9%) 1
    Nephrectomy 1/212 (0.5%) 1 0/108 (0%) 0
    Rhinoplasty 0/212 (0%) 0 1/108 (0.9%) 1
    Skin lesion excision 1/212 (0.5%) 1 0/108 (0%) 0
    Wisdom teeth removal 1/212 (0.5%) 1 0/108 (0%) 0
    Vascular disorders
    Aortic disorder 1/212 (0.5%) 1 0/108 (0%) 0
    Hot flush 0/212 (0%) 0 1/108 (0.9%) 1
    Hypertension 0/212 (0%) 0 2/108 (1.9%) 2
    Hypotension 3/212 (1.4%) 4 0/108 (0%) 0
    Peripheral coldness 1/212 (0.5%) 1 0/108 (0%) 0
    Shock 1/212 (0.5%) 1 0/108 (0%) 0
    Varicose vein 1/212 (0.5%) 1 0/108 (0%) 0

    Limitations/Caveats

    The ENDO Trial was stopped early due to a higher than anticipated rate of hepatic abscess (n=7).

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    PI to provide to Sponsor for review at least sixty (60) days in advance of submission for publication. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.

    Results Point of Contact

    Name/Title Brian Callahan
    Organization GI Dynamics, Inc
    Phone 781.357.3302
    Email bcallahan@gidynamics.com
    Responsible Party:
    GI Dynamics
    ClinicalTrials.gov Identifier:
    NCT01728116
    Other Study ID Numbers:
    • 09-1
    First Posted:
    Nov 16, 2012
    Last Update Posted:
    Feb 1, 2017
    Last Verified:
    Dec 1, 2016