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Evaluation of PillCam® Express Capsule Endoscopy Delivery System — RD-300  

Inflammatory Bowel Disease Clinical Trial

Official title:
Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.

Clinical Trial Description

Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope. The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies. Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section. This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01088646
Study type Interventional
Source Medtronic - MITG
Contact
Status Completed
Phase N/A
Start date October 2009
Completion date May 2010
View Details
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