NCT01433042

PillCam SB3 Capsule- Feasibility Study

Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

* 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

Conditions

• Small/Large Bowel

Interventions

Type	Name	Description
DEVICE	capsule endoscopy	capsule endoscopy procedure

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-09-13
• Last updated: 2019-08-01
• Results posted: 2014-02-04

Locations

4 sites across 4 countries: Israel, Romania, Spain, Sweden