Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects with Suspected Small Bowel Disease
This is a prospective, randomized, comparative multi-center site study.
Subjects with suspected SB disease will be screened to determine eligibility. Screening procedures will occur within 30 days of Day 0.
Each eligible subject will ingest both endoscopic capsules (CapsoCam SV-1 or and PillCam SB2 capsule) in a randomly assigned order 40 minutes apart. After ingestion of the second capsule, out-patient subjects may leave the clinic.
Simultaneous imaging without interference between the devices is possible since the PillCam SB2 capsule uses a frequency of 432 MHz to transmit images to the data recorder and the CapsoCam SV-1 uses non-wireless technology with storage of images within the capsule.
The recording phase will last at least 8 hours for each capsule. Based on published literature on the PillCam SB2 capsule, the majority of capsules will pass the ileocecal valve within that time. The PillCam SB2 data recorder and external sensors will be removed by the subject at 16:30 (4:30 PM) or at least 8 hours after ingestion on Day 0. Both the PillCam and CapsoCam capsules will be recovered by the subject using a stool trap and magnetic device, and returned to the study site on Day 3.
The primary clinical endpoint for efficacy is to compare the SB diagnostic yield of CapsoCam(TM) SV-1 to the PillCam SB2 (Given Imaging, Yoqneam, Israel) in subjects with suspected SB disease.
Subjects with suspected SB disease who are referred for capsule endoscopy will be screened to determine eligibility. Subjects who have provided informed consent, who are capable of comprehending the nature of the study, and who are likely to comply with the visit schedule are to be entered into the study provided they conform to the following 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 (SB) disease who are referred for capsule endoscopy (CE). Suspected small bowel conditions include suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn[Single Quote]s disease, [should have had patency capsule, CT or MR enterography before entry] suspected or known celiac disease, suspected SB 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.