PillCam SB3 Capsule- Feasibility Study
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients|
- Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians [ Time Frame: up to 6 months from end of recruitment ] [ Designated as safety issue: No ]precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians
|Study Start Date:||August 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: capsule endoscopy||
Device: capsule endoscopy
capsule endoscopy procedure
Other Name: CE
- Purpose of study- To assess the performance of PillCam SB3 capsule in detecting small bowel lesions in patients
- Study design- Feasibility study
- Number of subjects- Up to 200
- Subject population- Patients with symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy
- No of centers- 4
- Duration of enrollment up to 12 months from IRB approval to enroll study patients
- Duration of follow-up 1 week after capsule procedure.
- Primary objectives To evaluate the performance of SB-3 system in patients as per physician questionnaire
|Bikur Holim medical center|
|Servicio de Digestivo Hospital de Navarra|
|Skane University Hospital, Lund University|
|Principal Investigator:||Samuel Adler, Prof||Given Imaging Ltd.|