Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Completed · Not applicable

Conditions studied: Small Bowel Disease, Inflammatory Bowel Disease

In brief

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

Key facts

Study ID

NCT01088646

Run by

Medtronic - MITG

People needed

25

Starts

2009-10-01

Expected to finish

2010-05-01

Last updated by the study team

2020-10-22

Who can join

Age: 2 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 2 years
• Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel

You may not qualify if…

• Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
• Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
• Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
• Subject is pregnant
• Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule
• Subject has known allergy to conscious sedation medications
• Subject or legal guardian is not able to provide written informed consent

Where it is running

• Alabama Digestive Disorders Center, P. C. — Huntsville, Alabama, United States
• Alabama Liver and Digestive Specialists — Montgomery, Alabama, United States
• RANY -Research Associates of New York (NY Gastroenterology Associates) — New York, New York, United States

Full record on ClinicalTrials.gov

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