Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
Study Details
Study Description
Brief Summary
This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.
Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.
Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bowel preparation regimen -Control Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. |
Device: PillCam® COLON 2 procedure-CONTROL
Drug: Senna tablets
Drug: PEG
Drug: Metoclopramide
Drug: Erythromycin
Drug: SUPREP oral sulfate solution
Drug: Bisacodyl
|
| Experimental: Bowel preparation regimen-Test Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. |
Device: PillCam® COLON 2 procedure-CONTROL
Drug: Senna tablets
Drug: PEG
Drug: Metoclopramide
Drug: Erythromycin
Drug: Bisacodyl
Drug: SUPREP oral sulfate solution with Gastrografin
|
Outcome Measures
Primary Outcome Measures
- Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) [Within two weeks of study procedure]
The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).
Secondary Outcome Measures
- Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE [an expected average of 3 weeks from study procedure]
Will be assessed from RAPID video in total and by segment
- Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE [an expected average of 3 weeks from study procedure]
Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment
- Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE [an expected average of 3 weeks from study procedure]
Will be assessed from RAPID video in total and by segment
- Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE [an expected average of 3 weeks from study procedure]
Will be assesses by applicable case report form (CRF)
- Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE [Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.]
Will be assesses by applicable CRF
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is between 50 and 75 years of age.
-
Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of colorectal cancer (CRC) or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
-
Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Exclusion Criteria:
-
Subject with history of polyps (including those identified by computed tomography [CT], optical colonoscopy, sigmoidoscopy, etc.).
-
Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring screening in this time frame.
-
Subject with suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
-
Subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
-
Subject with dysphagia or any swallowing disorder.
-
Subject with serious medical conditions that would increase the risk associated with capsule or colonoscopy that are so severe that screening would have no benefit.
-
Subject with a cardiac pacemaker or other implanted electromedical device.
-
Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
-
Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range.
-
Subject with known gastrointestinal motility disorders.
-
Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.
-
Subject with comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
-
Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
-
Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).
-
Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group, LLC | Anniston | Alabama | United States | 36207 |
| 2 | Indiana University Hospital | Indianapolis | Indiana | United States | 46202 |
| 3 | Indianapolis Gastroenterology and Hepatology | Indianapolis | Indiana | United States | 46237 |
| 4 | Dayton Gastroenterology | Dayton | Ohio | United States | 45440 |
| 5 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 6 | Franklin Gastroenterology, PLLC | Franklin | Tennessee | United States | 37067 |
Sponsors and Collaborators
- Medtronic - MITG
Investigators
- Principal Investigator: Douglas K Rex, Dr.,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-205
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-CONTROL Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Period Title: Overall Study | ||
| STARTED | 60 | 62 |
| COMPLETED | 58 | 61 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test | Total |
|---|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-CONTROL Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin | Total of all reporting groups |
| Overall Participants | 60 | 62 | 122 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
58
96.7%
|
56
90.3%
|
114
93.4%
|
| >=65 years |
2
3.3%
|
6
9.7%
|
8
6.6%
|
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
53
|
53
|
53
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
31
51.7%
|
34
54.8%
|
65
53.3%
|
| Male |
29
48.3%
|
28
45.2%
|
57
46.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
60
100%
|
62
100%
|
122
100%
|
Outcome Measures
| Title | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) |
|---|---|
| Description | The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum). |
| Time Frame | Within two weeks of study procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon. |
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-CONTROL Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Measure Participants | 44 | 54 |
| Overall Excellent cleansing |
6.8
|
16.7
|
| Cecum Excellent cleansing |
14.0
|
14.6
|
| Ascending Excellent cleansing |
12.2
|
18.2
|
| Transverse Excellent cleansing |
10.6
|
14.6
|
| Descending Excellent cleansing |
9.5
|
18.5
|
| Rectum Excellent cleansing |
0
|
10.0
|
| Overall Good cleansing |
70.5
|
59.3
|
| Cecum Good cleansing |
54.0
|
52.7
|
| Ascending Good cleansing |
63.3
|
60.0
|
| Transverse Good cleansing |
61.7
|
60.0
|
| Descending Good cleansing |
73.8
|
63.0
|
| Rectum Good cleansing |
56.1
|
52.0
|
| Overall Fair cleansing |
22.7
|
24.1
|
| Cecum Fair cleansing |
30.0
|
30.9
|
| Ascending Fair cleansing |
22.5
|
21.8
|
| Transverse Fair cleansing |
27.7
|
25.5
|
| Descending Fair cleansing |
16.7
|
18.5
|
| Rectum Fair cleansing |
46.5
|
36.0
|
| Overall Poor cleansing |
0
|
0
|
| Cecum Poor cleansing |
2.0
|
1.8
|
| Ascending Poor cleansing |
2.0
|
0
|
| Transverse Poor cleansing |
0
|
0
|
| Descending Poor cleansing |
0
|
0
|
| Rectum Poor cleansing |
2.4
|
2.0
|
| Title | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE |
|---|---|
| Description | Will be assessed from RAPID video in total and by segment |
| Time Frame | an expected average of 3 weeks from study procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments. |
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Control Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Measure Participants | 47 | 55 |
| Overall (any size) |
46.8
78%
|
58.2
93.9%
|
| Cecum (any size) |
6.0
10%
|
14.6
23.5%
|
| Ascending (any size) |
14.0
23.3%
|
9.1
14.7%
|
| Transverse (any size) |
4.3
7.2%
|
7.3
11.8%
|
| Descending (any size) |
31.9
53.2%
|
29.1
46.9%
|
| rectum (any size) |
24.4
40.7%
|
32.0
51.6%
|
| Overall (polyps ≥6mm) |
21.3
35.5%
|
36.4
58.7%
|
| Cecum (polyps ≥6mm) |
2.0
3.3%
|
12.7
20.5%
|
| Ascending (polyps ≥6mm) |
2.0
3.3%
|
3.6
5.8%
|
| Transverse (polyps ≥6mm) |
4.3
7.2%
|
7.3
11.8%
|
| Descending (polyps ≥6mm) |
12.8
21.3%
|
16.4
26.5%
|
| Rectum (polyps ≥6mm) |
7.3
12.2%
|
6.0
9.7%
|
| Overall (polyps ≥10mm) |
8.5
14.2%
|
14.6
23.5%
|
| Cecum Overall (polyps ≥10mm) |
0
0%
|
7.3
11.8%
|
| Ascending Overall (polyps ≥10mm) |
2.0
3.3%
|
3.6
5.8%
|
| Transverse (polyps ≥10mm) |
0
0%
|
1.8
2.9%
|
| Descending (polyps ≥10mm) |
4.3
7.2%
|
3.6
5.8%
|
| Rectum (polyps ≥10mm) |
4.9
8.2%
|
2.0
3.2%
|
| Title | Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE |
|---|---|
| Description | Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment |
| Time Frame | an expected average of 3 weeks from study procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam. |
| Arm/Group Title | Bowel Preparation Regimen - Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Control Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure- Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Measure Participants | 46 | 55 |
| Median (Full Range) [hours] |
2.8
|
2.4
|
| Title | Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE |
|---|---|
| Description | Will be assessed from RAPID video in total and by segment |
| Time Frame | an expected average of 3 weeks from study procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol analysis set |
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure- Control Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Measure Participants | 52 | 55 |
| Number [percentage of participants] |
76.9
128.2%
|
90.9
146.6%
|
| Title | Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE |
|---|---|
| Description | Will be assesses by applicable case report form (CRF) |
| Time Frame | an expected average of 3 weeks from study procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake <1h and > 2.15h, Morning PEG intake <1h and >2:15 h, Capsule ingestion l<45 min or >75 min after PEG intake , Overall PEG intake volume is less than 3 liters |
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Control Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Measure Participants | 51 | 55 |
| Number [percentage of participants] |
80.4
134%
|
90.9
146.6%
|
| Title | Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE |
|---|---|
| Description | Will be assesses by applicable CRF |
| Time Frame | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set |
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test |
|---|---|---|
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Control Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin |
| Measure Participants | 59 | 62 |
| Number [percentage of participants with >1 AE] |
3.4
5.7%
|
19.4
31.3%
|
Adverse Events
| Time Frame | Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test | ||
| Arm/Group Description | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Control Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sulfate solution Bisacodyl | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository. PillCam® COLON 2 procedure-Test Senna tablets PEG Metoclopramide Erythromycin Bisacodyl SUPREP oral sulfate solution with Gastrografin | ||
All Cause Mortality |
||||
| Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 1/62 (1.6%) | ||
| Eye disorders | ||||
| Chronic Sinusitis | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Bowel Preparation Regimen -Control | Bowel Preparation Regimen-Test | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/59 (3.4%) | 12/62 (19.4%) | ||
| Ear and labyrinth disorders | ||||
| Eye swelling | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
| Gastrointestinal disorders | ||||
| abdominal pain | 2/59 (3.4%) | 3 | 1/62 (1.6%) | 1 |
| Diarrhoea | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
| Dyspesia | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
| Haemorrhoids | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
| Nausea | 0/59 (0%) | 0 | 4/62 (6.5%) | 4 |
| Proctalgia | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
| vomiting | 0/59 (0%) | 0 | 2/62 (3.2%) | 3 |
| General disorders | ||||
| Irritation | 0/59 (0%) | 0 | 2/62 (3.2%) | 2 |
| Injury, poisoning and procedural complications | ||||
| Muscle strain | 0/59 (0%) | 0 | 1/62 (1.6%) | 1 |
| Nervous system disorders | ||||
| Haedache | 1/59 (1.7%) | 1 | 2/62 (3.2%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Prior written consent is required for PI to independently publish any study results before a multi-center publication is released. If a multi-center manuscript is not submitted for publication within 1 year after completion of the Trial, PI shall have the right to Publish results. Sponsor shall respond within 45 days and shall have the right to delay the Publication for an additional 90.
Results Point of Contact
| Name/Title | Liron Bar Yaakov |
|---|---|
| Organization | Given Imaging (a Medtronic company) |
| Phone | +97249097946 |
| liron.bar-yaakov@covidien.com |
- MA-205