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

NCT ID: NCT00555737

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2007-07-31

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.

Detailed Description

Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.

These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.

Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.

Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.

The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.

Capsule Endoscopy could become an important tool for the non-invasive assessment of small bowel mucosa in GSE.

Conditions

Celiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Capsule Endoscopy

Given® Diagnostic system with Pillcam SB

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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:

1. Chronic diarrhea

2. Weight loss

3. Abdominal cramps

4. History of spontaneous abortion

5. Iron deficiency anemia

6. Osteoporosis

7. Infertility

8. Hypoalbuminaemia

9. Low cholesterol

10. Low prothrombin activity

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Given Imaging Ltd.

Principal Investigators

Roberto de Franchis, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Maggiore - Policlinico, Milano, Italy

Locations

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

Countries

United States; Finland; Italy

Other Identifiers

MA-23

Identifier Type: -

Identifier Source: org_study_id