Endoscopic Implantation of Enteryx for the Treatment of GERD
Study Details
Study Description
Brief Summary
The study objective is to assess the long term safety and effectiveness of Enteryx device in commercial use. The long-term effects beyond one year of treatment with Enteryx have not been established.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
The Enteryx procedure kit is indicated for endoscopic injection into the region of the lower esophageal sphincter (LES) for the treatment of symptoms due to gastroesophageal reflux disease (GERD) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors (PPI's).
The study design consists of two parts, Part A and Part B. Part A will enroll patients who received Enteryx treatments after approval and Part B will enroll patients previously enrolled and treated in the IDE study #G000065. In total there will be at least 300 patients enrolled in Part A and Part B with 36 months of follow-up Part A: Approximately 150 to 200 patients will be enrolled from 22 centers. After patients have determined with their physicians that Enteryx is an appropriate course of therapy for their GERD symptoms, they will be asked to participate in this trial. Patients will be followed for adverse events, medication use, and GERD-HRQL symptoms at baseline, day of treatment, one month, six months, twelve months, twenty-four months, and thirty-six months. The final study visit will be thirty-six months after the last Enteryx injection. In addition, all Part A patients will be contacted by the Site at least quarterly to obtain current adverse event information. This adverse event information will be solicited from the Site by the Sponsor at least quarterly. Part B: All US IDE patients (approximately 150 patients) will be asked to enroll. Patients will be followed for adverse events, medication use, and GERD-HRQL symptoms at two visits beyond the follow-up prescribed in the IDE study, namely 24 and 36 months after the last Enteryx injection received in the IDE study. Parts A and B: There will be a breakdown of adverse events based on retreatment status. Any subsequent procedures or interventions related to GERD or Enteryx, whether surgical (such as fundoplication) or non-surgical (such as an alternative endoscopic treatment for GERD), will be collected and reported.
H0: (Null hypothesis): Proportion of patients exhibiting clinically significant improvement in reduction of PPI therapy ≤ 0.5
Ha: (Alt. hypothesis): Proportion of patients exhibiting clinically significant improvement in reduction of PPI therapy > 0.5
The Sponsor will examine the proportion of patients who have clinically significant reduction in PPI therapy at the 12, 24 and 36 month follow-ups, in an identical manner to that used for the patients in the IDE trial. The "clinically significant reduction" is defined as either elimination of medication use or reduction in dosage of ≥50%. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction. The hypothesis is tested by p-value and construction of the exact 95% Clopper-Pearson confidence intervals around the observed proportion of patients who meet the criterion for success. The longitudinal post-procedure follow-up data across time (repeated measures) will be analyzed to determine patterns and trends for all primary endpoints. The hypothesis stated above will also be evaluated in the subset of patients that underwent retreatment prior to amendment v.14Oct05.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Those receiving Enteryx treatment |
Drug: Enteryx
|
Outcome Measures
Primary Outcome Measures
- Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients. [3 years either baseline to 12m, baseline to 24m, baseline to 36m]
Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction.
Eligibility Criteria
Criteria
Inclusion Criteria:
- GERD responsive to and requiring daily PPI therapy
Exclusion Criteria:
- Esophageal varices, particularly related to portal hypertension • Patients whom the physician determines to be a poor candidate for endoscopic procedures and/or anesthesia.
Patients must also be willing to allow their data to be shared with the Sponsor and FDA.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
Investigators
- Principal Investigator: Yang Chen, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2003P000277
Study Results
Participant Flow
| Recruitment Details | Referral patients experiencing moderate to severe GERD |
|---|---|
| Pre-assignment Detail | Those not meeting inclusion/exclustion criteria were not included |
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | Patients that are GERD responsive and requiring daily PPI therapy |
| Period Title: Overall Study | |
| STARTED | 16 |
| COMPLETED | 12 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | Patients experiencing moderate GERD |
| Overall Participants | 16 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
10
62.5%
|
| >=65 years |
6
37.5%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
61
(13)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
62.5%
|
| Male |
6
37.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
16
100%
|
Outcome Measures
| Title | Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients. |
|---|---|
| Description | Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction. |
| Time Frame | 3 years either baseline to 12m, baseline to 24m, baseline to 36m |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall Number of Participants Analyzed (16) will differ at 12m, 24m, and 36m intervals due to patients who were available at the given follow-up interval. |
| Arm/Group Title | Enteryx Treatment |
|---|---|
| Arm/Group Description | Those receiving Enteryx treatment Enteryx |
| Measure Participants | 16 |
| clinically significant reduction of PPI usage 12m |
56.25
351.6%
|
| clinically significant reduction of PPI usage 24m |
45.45
284.1%
|
| clinically significant reduction of PPI usage 36m |
50.00
312.5%
|
Adverse Events
| Time Frame | 3 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Group 1 - Single Arm | |
| Arm/Group Description | Those experiencing GERD | |
All Cause Mortality |
||
| Group 1 - Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Group 1 - Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/16 (62.5%) | |
| Cardiac disorders | ||
| Flutter Fibrillation | 1/16 (6.3%) | 1 |
| Severe Chest Pain / Myocardial Infarction | 1/16 (6.3%) | 1 |
| Chest Pain secondary to Coronary Artery Disease | 1/16 (6.3%) | 2 |
| Heart Attack | 1/16 (6.3%) | 1 |
| Gastrointestinal disorders | ||
| Nissen Fundoplication for Severe GERD | 1/16 (6.3%) | 1 |
| Bleeding Esophageal Ulcer | 1/16 (6.3%) | 1 |
| Esophagitis | 1/16 (6.3%) | 1 |
| Gastritis | 1/16 (6.3%) | 2 |
| General disorders | ||
| Retrosternal Chest Pain | 1/16 (6.3%) | 1 |
| Rigors "Shaking Chills" | 1/16 (6.3%) | 1 |
| Infections and infestations | ||
| Chemical Mediastinitis | 1/16 (6.3%) | 1 |
| C-Diff Colitis | 1/16 (6.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Torn Rotator Cuff | 1/16 (6.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Throat Cancer | 1/16 (6.3%) | 1 |
| Malignant Nodule in Thyroid | 1/16 (6.3%) | 1 |
| Nervous system disorders | ||
| Headache | 1/16 (6.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pleural Effusion | 2/16 (12.5%) | 2 |
| Pneumothorax | 1/16 (6.3%) | 1 |
| Pleuritic Chest Pain with Inspiration | 1/16 (6.3%) | 1 |
| Pneumomediastinum | 1/16 (6.3%) | 1 |
| Pneumonia | 1/16 (6.3%) | 1 |
| Surgical and medical procedures | ||
| Hiatal Hernia Repair | 1/16 (6.3%) | 1 |
| Nissen Fundoplication Repair with Hospital Stay for GERD and Pulmonary Symptoms | 1/16 (6.3%) | 1 |
| Nissen Fundoplication for GERD. Hospitalized for 2 days post surgery. | 1/16 (6.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Group 1 - Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 16/16 (100%) | |
| Gastrointestinal disorders | ||
| Worse Than Ever Heartburn. Woke Pt. from Sleep. | 1/16 (6.3%) | 1 |
| Dysphagia | 6/16 (37.5%) | 7 |
| Nausea | 3/16 (18.8%) | 4 |
| Constipation | 1/16 (6.3%) | 1 |
| Hiatal Hernia | 1/16 (6.3%) | 1 |
| Schatzski's Ring | 1/16 (6.3%) | 1 |
| Diverticulosis of Sigmoid Colon | 1/16 (6.3%) | 1 |
| Excessive Gas | 1/16 (6.3%) | 1 |
| More servere hearburn than Baseline | 1/16 (6.3%) | 1 |
| Burping | 1/16 (6.3%) | 1 |
| Abdominal discomfort | 1/16 (6.3%) | 1 |
| Bleeding gastric ulcer | 1/16 (6.3%) | 2 |
| Exacerbation of reflux due to medication taken for pneumonia | 1/16 (6.3%) | 1 |
| Gastric fistula | 1/16 (6.3%) | 1 |
| Vomiting | 1/16 (6.3%) | 1 |
| Diarrhea | 1/16 (6.3%) | 1 |
| Exacerbated GERD symptoms - gagging, coughing, mucus due to stress when patient's mother was ill. | 1/16 (6.3%) | 1 |
| Worsening of GERD Symptoms | 2/16 (12.5%) | 2 |
| More severe heartburn than baseline | 1/16 (6.3%) | 1 |
| Exacerbation of GERD symptoms similar to baseline | 1/16 (6.3%) | 1 |
| Increase in severity of nausea | 1/16 (6.3%) | 1 |
| Increased Burping | 1/16 (6.3%) | 1 |
| Difficulty Swallowing | 1/16 (6.3%) | 1 |
| Trouble Swallowing | 1/16 (6.3%) | 1 |
| General disorders | ||
| Pain in the middle of Chest brought on by physical activity | 1/16 (6.3%) | 1 |
| Retrosternal Chest Pain | 9/16 (56.3%) | 9 |
| Patient with complaint of left lateral wall discomfort in left axilla. Occasional/short lasting | 1/16 (6.3%) | 1 |
| Low grade fever | 1/16 (6.3%) | 1 |
| Weakness | 1/16 (6.3%) | 1 |
| Mild Retrosternal Chest Pain | 1/16 (6.3%) | 1 |
| Chest Pain | 2/16 (12.5%) | 2 |
| Infections and infestations | ||
| Diverticulitis | 1/16 (6.3%) | 1 |
| Upper Respiratory Infection | 1/16 (6.3%) | 2 |
| Minor Cold | 1/16 (6.3%) | 1 |
| Pneumonia | 1/16 (6.3%) | 1 |
| Viral illness accompanied by headache, nauseau, and vomiting | 1/16 (6.3%) | 1 |
| Cold like symtoms | 1/16 (6.3%) | 1 |
| Tooth abscess | 1/16 (6.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| Torn ligmament in left shoulder | 1/16 (6.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Herniated Cervical Disc | 1/16 (6.3%) | 1 |
| Arthritic low back pain | 1/16 (6.3%) | 1 |
| Osteoporosis | 1/16 (6.3%) | 1 |
| Nervous system disorders | ||
| Headache | 1/16 (6.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Shortness of Breath brough on by physical activity | 1/16 (6.3%) | 1 |
| Coughing | 1/16 (6.3%) | 1 |
| Pleural effusion | 1/16 (6.3%) | 1 |
| Sinusitis with asthma exacerbation | 1/16 (6.3%) | 1 |
| Worsening of asthma | 1/16 (6.3%) | 1 |
| Asthma Attack | 1/16 (6.3%) | 1 |
| Sleep apnea | 1/16 (6.3%) | 1 |
| Asthma Exacerbation | 1/16 (6.3%) | 1 |
| Vascular disorders | ||
| High Blood Pressure | 1/16 (6.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director, Endoscopy Clinical Affairs |
|---|---|
| Organization | Boston Scientific |
| Phone | 1-508-333-1015 |
- 2003P000277