Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

Study Overview
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Brief Summary
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This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy. This study will also use to evaluate the administrative feasibility and data management of study design.

Official Title
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Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

Conditions
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Colorectal Lesions

Intervention / Treatment
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* Device: PillCam Colon 2
* Device: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 50 - 75 years of age, and an appropriate candidate for polyp screening. Subject received an explanation about the nature of the study and agrees to provide written informed consent. Exclusion Criteria: Subject has a history of colorectal cancer Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.), Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years. Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age. Subject is suspected or diagnosed with familial adenomatous polyposis. Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety Subject is suspected or diagnosed with bowel obstruction. Subject has dysphagia or any swallowing disorder. Subject has congestive heart failure. Subject has Diabetes. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other 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 intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy. Subject with strictures, fistulas and/or chronic constipation. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters. Subject with known 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PillCam Colon 2 and Standard Colonoscopy<br>All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy. | Device: PillCam Colon 2<br>* Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.<br>Device: Colonoscopy<br>* The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks | 
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks | 
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyps, capsule endoscopy, colonoscopy