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PillCam SBC System Functionality in Established and Suspected IBD Patients — PIANO  

Crohn's Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02742714
Study type Interventional
Source Medtronic - MITG
Contact
Status Completed
Phase N/A
Start date July 2016
Completion date March 2017
View Details
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