At a glance
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Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients
In Brief
A clinical study evaluating capsule endoscopy for Small/Large Bowel. Completed, enrolled 225 participants across 4 sites in 4 countries.
Detailed Summary
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy. Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease. Preparation for procedure will include 12 hours fasting prior to the capsule ingestion Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion. Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured
Study Details
Timeline
Interventions
capsule endoscopy procedure