Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)

Completed

Conditions studied: Celiac Disease

In brief

The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.

Key facts

Study ID

NCT00555737

Run by

Medtronic - MITG

People needed

102

Starts

2003-11-01

Expected to finish

2007-07-01

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age is 18 years or older
• Patient agrees to sign the Informed Consent Form
• Patient has positive celiac serology or negative celiac serology + IgA deficiency and suffers from one or more of the following symptoms and/or abdominal biochemical values:
• Chronic diarrhea
• Weight loss
• Abdominal cramps
• History of spontaneous abortion
• Iron deficiency anemia
• Osteoporosis
• Infertility
• Hypoalbuminaemia
• Low cholesterol
• Low prothrombin activity

You may not qualify if…

• Patient is known or is suspected to suffer from intestinal obstruction.
• Patient has a cardiac pacemaker or other electro-medical device.
• Patient suffers from severe swallowing disorder or Zenker's diverticulum
• Patient has any condition, which precludes compliance with study and/or device instructions.
• Female patient is pregnant
• Patient suffers from life threatening conditions
• Patient is currently participating in another clinical study.

Where it is running

• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of Tampere Medical School — Tampere, Finland
• Ospedale Maggiore - Policlinico — Milan, Italy
• Universita Cattolica del Sacro Cuore — Rome, Italy
• San Giovanni A.S. Hospital — Torino, Italy

Full record on ClinicalTrials.gov

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