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

NCT00555737 | Completed

• 1 other identifier: MA-23
• Study Type: observational
• Target: 102
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Celiac Disease

Keywords

Celiac Disease; Capsule Endoscopy; small Bowel Disease

Outcome Measures

Primary Outcomes (1)

• The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin

  within 14 days of enrollment

Secondary Outcomes (1)

• Longitudinal extent of villous changes in the small bowel will be evaluated.

  within 14 days of enrollment

Interventions

Capsule Endoscopy DEVICE

Given® Diagnostic system with Pillcam SB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

clinic paitnets with known Gluten sensitivity (Celaic).

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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (5)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Tampere Medical School

Tampere, Finland

Location

Ospedale Maggiore - Policlinico

Milan, 20122, Italy

Location

Universita Cattolica del Sacro Cuore

Rome, Italy

Location

San Giovanni A.S. Hospital

Torino, Italy

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Roberto de Franchis, MD, Prof.

  Ospedale Maggiore - Policlinico, Milano, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: November 1, 2003
• Study Completion: July 1, 2007
• Last Updated: July 31, 2019

Record last verified: 2007-11

Locations

FI (1); US (1); IT (3)