NCT02742714

PillCam SBC System Functionality in Established and Suspected IBD Patients

Evaluation of PillCam SBC Capsule Endoscopy System Performance in Established and Suspected IBD Patients to Assess System Functionality by Visualizing and Assessing the Small Bowel and Colon

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammatory Small Bowel Disease
• Crohn's Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-04-19
• Last updated: 2017-09-19

Locations

5 sites across 3 countries: Israel, Italy, Spain