Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.

Detailed Description
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This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.

Official Title
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Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease

Conditions
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Intestinal Disease, Inflammatory Bowel Disease, Crohn Disease, Ulcer, Celiac Disease

Intervention / Treatment
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* Device: PillCam SB2 capsule
* Device: CapsoCam SV-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 to 85 years of age (inclusive). Willing and able to provide written informed consent. Subjects with suspected small bowel disease who are referred for capsule endoscopy. Suspected small bowel disease includes suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn's Disease [should have had patency capsule, CT or MR enterography before entry], suspected or known celiac disease, suspected small bowel tumor or familial polyposis syndrome. If subject was referred for capsule endoscopy (CE) for identification of occult GI bleeding, has the subject undergone a non-diagnostic esophagoduodenoscopy and colonoscopy as part of their evaluation, OR has the subject had continued bleeding requiring transfusion since the initial evaluation, OR does the subject have the following hematocrit values <31% in males or <28% in females. Exclusion Criteria: Subjects who had a prior negative capsule endoscopy (within 1 year of study). Known or suspected obstruction or stricture unless patency capsule confirms patency. Known or suspected gastrointestinal perforation. Known or suspected small bowel diverticuli. Known swallowing disorder or the inability or unwillingness to swallow pills. Radiation or chemotherapy induced enteritis. History of Zenker's or known duodenal or jejunal diverticula. Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms Subjects who are high risk for undergoing surgical interventions (i.e., to CONFIDENTIAL CapsoVision Protocol SV-1 Revision: October 17, 2011 7 remove the capsule when capsule retention occurs). Subjects with DNR/DNI do not resuscitate/do not intubate status. Known or suspected gastrointestinal dysmotility. Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant. History of skin reaction to adhesives. Subjects who in the Investigator's opinion should not consume the 2L GoLytely and 10 mg bisacodyl study drugs, because it could pose a significant additional risk to the subject because of the subject's medical condition. Subjects who are scheduled for an MRI within 30 days of the last study visit. Pregnancy; females of childbearing potential must have a negative urine pregnancy test at screening. Prisoners. Mental and/or physical condition precluding compliance with the study and/or device instructions. Participation in another clinical study within past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PillCam SB2 then CapsoCam SV-1<br>PillCam SB2 capsule then CapsoCam SV-1 capsule | Device: PillCam SB2 capsule<br>* Capsule Endoscopy system<br>* Other names: capsule endoscopy system;Device: CapsoCam SV-1<br>* Capsule endoscopy<br>* Other names: Capsule endoscopy;|
| Other: CapsoCam SV-1 then PillCam SB2<br>CapsoCam SV-1 capsule then PillCam SB2 capsule | Device: PillCam SB2 capsule<br>* Capsule Endoscopy system<br>* Other names: capsule endoscopy system;Device: CapsoCam SV-1<br>* Capsule endoscopy<br>* Other names: Capsule endoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal vs Abnormal, Overall Impression | The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement. | Study Completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2 | Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers. | Study Completion | 
| Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 | Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result. | Study Completion | 
| Preference Between CapsoCam SV-1 and PillCam SB2 | Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects | Study Completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal disease, inflammatory bowel disease, crohn disease, ulcer, celiac disease, angioectasia, polyp