PillCam SB3 Capsule- Feasibility Study

Not Applicable

Completed

• Conditions: Small/Large Bowel
• Interventions: Device: capsule endoscopy

• Registration Number: NCT01433042
• Lead Sponsor: Medtronic - MITG

Brief 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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-11
• Study First Posted: 2011-09-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-02-12
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-15
• Results First Posted: 2014-02-04
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capsule endoscopy	capsule endoscopy	-

Primary Outcome Measures

Name	Time	Method
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians	up to 6 months from end of recruitment	precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians

Trial Locations

Locations (4)

Bikur Holim medical center; 🇮🇱 Jerusalem, Israel

Servicio de Digestivo Hospital de Navarra; 🇪🇸 Pamplona, Spain

University Hospital; 🇷🇴 Bucharest, Romania

Skane University Hospital, Lund University; 🇸🇪 Lund, Sweden