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

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00555737
First received: November 8, 2007
Last updated: March 25, 2009
Last verified: November 2007
History of Changes
  Purpose

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


Condition Intervention
Celiac Disease
 Device: Capsule Endoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • 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 [ Time Frame: within 14 days of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Longitudinal extent of villous changes in the small bowel will be evaluated. [ Time Frame: within 14 days of enrollment ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: November 2003
Study Completion Date: July 2007
Intervention Details:
    Device: Capsule Endoscopy
    Given® Diagnostic system with Pillcam SB
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

clinic paitnets with known Gluten sensitivity (Celaic).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555737

Locations
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Finland
University of Tampere Medical School
Tampere, Finland
Italy
Ospedale Maggiore - Policlinico
Milano, Italy, 20122
Universita Cattolica del Sacro Cuore
Rome, Italy
San Giovanni A.S. Hospital
Torino, Italy
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Roberto de Franchis, MD, Prof. Ospedale Maggiore - Policlinico, Milano, Italy
  More Information

No publications provided

Responsible Party: Corporate Director Clinical Affairs, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00555737     History of Changes
Other Study ID Numbers: MA-23
Study First Received: November 8, 2007
Last Updated: March 25, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Given Imaging Ltd.:
Celiac Disease
Capsule Endoscopy
small Bowel Disease

Additional relevant MeSH terms:
Celiac Disease
Intestinal Diseases
Malabsorption Syndromes
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013