Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)
|First Received Date ICMJE||November 8, 2007|
|Last Updated Date||March 25, 2009|
|Start Date ICMJE||November 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE
||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 ]|
|Change History||Complete list of historical versions of study NCT00555737 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Longitudinal extent of villous changes in the small bowel will be evaluated. [ Time Frame: within 14 days of enrollment ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE
||Longitudinal extent of villous changes in the small bowel will be evaluated. [ Time Frame: within 14 days of enrollment ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)|
|Official Title ICMJE||Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy|
|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.|
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
|Study Population||clinic paitnets with known Gluten sensitivity (Celaic).|
|Condition ICMJE||Celiac Disease|
|Intervention ICMJE||Device: Capsule Endoscopy
Given® Diagnostic system with Pillcam SB
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States, Finland, Italy|
|Removed Location Countries|
|NCT Number ICMJE||NCT00555737|
|Other Study ID Numbers ICMJE||MA-23|
|Has Data Monitoring Committee||No|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Corporate Director Clinical Affairs, Given Imaging Ltd.|
|Study Sponsor ICMJE||Given Imaging Ltd.|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Given Imaging Ltd.|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP