PillCam SBC System Functionality in Established and Suspected IBD Patients

Not Applicable

Completed

• Conditions: Crohn's Disease; Chronic Inflammatory Small Bowel Disease
• Interventions: Device: PillCam SBC system

• Registration Number: NCT02742714
• Lead Sponsor: Medtronic - MITG

Brief Summary

This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.

Detailed Description

The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.

Fifty established and suspected IBD patients (at least half of them with established crohn disease (CD)) with active or quiescent disease activity, aged 18 years and up, with no symptomatic stricture or known obstruction that would prevent capsule passage will be enrolled in up to 6 medical sites in Israel and Europe.

Patients will undergo bowel prep, followed by a PillCam SBC capsule examination. Patency capsule may precede PillCam SBC ingestion according to physician discretion.

The PillCam Software videos will be evaluated by local site reader following a Subjective Assessment Form fulfillment.

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Study Start: 2016-07
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-17
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PillCam SBC	PillCam SBC system	The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.

Primary Outcome Measures

Name	Time	Method
Successful SBC procedure in terms of video creation and report generation per training instructions	4 weeks	Success procedures are being measured. Only if both video and report will be created it will be defined as success.

Trial Locations

Locations (5)

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy

The Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel