PillCam SB3 Capsule- Feasibility Study

Small/Large Bowel Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Small/Large Bowel

• NCT number: NCT01433042
• Study type: Interventional
• Source: Medtronic - MITG
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Completion date: October 2012