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

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

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.

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.

Inclusion Criteria:

1. Male or female between 18 to 85 years of age (inclusive).
2. Willing and able to provide written informed consent.
3. 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.
4. 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:

1. Subjects who had a prior negative capsule endoscopy (within 1 year of study).
2. Known or suspected obstruction or stricture unless patency capsule confirms patency.
3. Known or suspected gastrointestinal perforation.
4. Known or suspected small bowel diverticuli.
5. Known swallowing disorder or the inability or unwillingness to swallow pills.
6. Radiation or chemotherapy induced enteritis.
7. History of Zenker's or known duodenal or jejunal diverticula.
8. Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms
9. 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).
10. Subjects with DNR/DNI "do not resuscitate/do not intubate" status.
11. Known or suspected gastrointestinal dysmotility.
12. Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant.
13. History of skin reaction to adhesives.
14. 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.
15. Subjects who are scheduled for an MRI within 30 days of the last study visit.
16. Pregnancy; females of childbearing potential must have a negative urine pregnancy test at screening.
17. Prisoners.
18. Mental and/or physical condition precluding compliance with the study and/or device instructions.
19. Participation in another clinical study within past 30 days.