Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

Conditions
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Colorectal Cancer Screening

Intervention / Treatment
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* Device: PillCam® COLON 2 procedure-CONTROL
* Drug: Senna tablets
* Drug: PEG
* Drug: Metoclopramide
* Drug: Erythromycin
* Drug: SUPREP oral sulfate solution
* Drug: Bisacodyl
* Drug: SUPREP oral sulfate solution with Gastrografin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bowel preparation regimen -Control<br>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<br> <br> Drug: Senna tablets<br> <br> Drug: PEG<br> <br> Drug: Metoclopramide<br> <br> Drug: Erythromycin<br> <br> Drug: SUPREP oral sulfate solution<br> <br> Drug: Bisacodyl<br> <br> |
| Experimental: Bowel preparation regimen-Test<br>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<br> <br> Drug: Senna tablets<br> <br> Drug: PEG<br> <br> Drug: Metoclopramide<br> <br> Drug: Erythromycin<br> <br> Drug: Bisacodyl<br> <br> Drug: SUPREP oral sulfate solution with Gastrografin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | 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). | Within two weeks of study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Will be assessed from RAPID video in total and by segment | an expected average of 3 weeks from study procedure | 
| Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE | Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment | an expected average of 3 weeks from study procedure | 
| Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE | Will be assessed from RAPID video in total and by segment | an expected average of 3 weeks from study procedure | 
| Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE | Will be assesses by applicable case report form (CRF) | an expected average of 3 weeks from study procedure | 
| Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | Will be assesses by applicable CRF | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyps, Capsule endoscopy, Bowel preparation regimen, Average risk patients for colorectal cancer screening