Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Study Overview
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Brief Summary
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The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.

Detailed Description
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Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).

Official Title
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Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Conditions
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Colonoscopy, Endoscopy

Intervention / Treatment
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* Other: PillCam® COLON 2 procedure using MgC boosts
* Other: PillCam® COLON 2 procedure using Suprep boosts
* Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 50 - 75 years of age. Subject received an explanation about the nature of the study and agrees to provide written informed consent. Exclusion Criteria: Subject has dysphagia or any swallowing disorder Subject has congestive heart failure Subject has Diabetes type I. Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator Subject has a cardiac pacemaker or other implanted electro medical device. Subject has any allergy or other known contraindication to the medications used in the study Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy. Subject with gastrointestinal motility disorders Subject has known delayed gastric emptying Subject has any condition, which precludes compliance with study and/or device instructions. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. Subject suffers from life threatening conditions Subject currently participating in another clinical 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: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MgC boosts<br>Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered MgC boosts. | Other: PillCam® COLON 2 procedure using MgC boosts<br>* Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.<br>|
| Experimental: Suprep boosts<br>Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered Suprep boosts | Other: PillCam® COLON 2 procedure using Suprep boosts<br>* Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts<br>|
| Experimental: Suprep boosts - Reduced dose<br>Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered a reduced dose of Suprep boosts | Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts<br>* Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsule excretion rate |  | 10 hours post capsule ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of PillCam® COLON 2 excretion times |  | Up to 12 hours and at least 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CE, colonoscopy, colon, Eligable for colon evaluation