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

Medtronic

Status: Completed

Conditions: Celiac Disease

Treatments: Device: Capsule Endoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT00555737

MA-23

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.