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

November 8, 2007
March 25, 2009
November 2003
Not Provided
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 ]
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 ]
Complete list of historical versions of study NCT00555737 on ClinicalTrials.gov Archive Site
Longitudinal extent of villous changes in the small bowel will be evaluated. [ Time Frame: within 14 days of enrollment ] [ Designated as safety issue: No ]
Longitudinal extent of villous changes in the small bowel will be evaluated. [ Time Frame: within 14 days of enrollment ]
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Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)
Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

clinic paitnets with known Gluten sensitivity (Celaic).

Celiac Disease
Device: Capsule Endoscopy
Given® Diagnostic system with Pillcam SB
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
July 2007
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   Italy
 
NCT00555737
MA-23
No
Corporate Director Clinical Affairs, Given Imaging Ltd.
Given Imaging Ltd.
Not Provided
Principal Investigator: Roberto de Franchis, MD, Prof. Ospedale Maggiore - Policlinico, Milano, Italy
Given Imaging Ltd.
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP