Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487396
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2007-06-14
Brief Title:
Evaluation of Capsule Endoscopy in Patients With Suspected Crohns Disease
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
Evaluation of Capsule Endoscopy in Patients With Suspected Crohns Disease
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MA-51
Brief Summary:
The aim of this study is to validate the ability of Capsule Endoscopy CE to accurately diagnose small bowel SB Crohns disease in patients with symptoms of abdominal pain and diarrhea
The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing
The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing
Detailed Description:
Crohns disease is a chronic inflammatory disorder IBD affecting any part of the gastrointestinal tract but frequently involves the small and large bowel Typical presenting symptoms include abdominal pain and diarrhea Patients with this disorder may also have extraintestinal manifestations including arthritis uveitis and aphthous stomatitis erythema nodosum and pyoderma gangrenosum The etiology of Crohns disease is unknown It affects populations around the globe and occurs at any age but it has a predilection to affect those between the ages of 15 and 35
While about one half of patients have involvement of the ileum and large bowel another third have disease isolated to the small bowel Frequently small bowel Crohns disease can be difficult to diagnose using the traditional methods of evaluation including colonoscopy with ileoscopy and contrast radiography Mucosal features of Crohns disease are often subtle and difficult to identify by small bowel follow through SBFT The SBFT has traditionally been relied on to evaluate the small intestine for evidence of Crohns disease but it has been shown to have a relatively low accuracy of only 30 This has led to delays in the diagnosis of Crohns disease with reports ranging from one to three years
In the past few years capsule endoscopy has sparked renewed interest in the investigation of IBD and Crohns disease of the small bowel A PillCam SB2 capsule Given Imaging Ltd Yoqneam Israel is an ingestible disposable video camera that transmits high quality images of the small intestinal mucosa This enables the small intestine to be readily accessible to physicians investigating for the presence of small bowel disorders which in the past was inaccessible to physicians A number of small pilot studies demonstrated capsule endoscopy efficacy in diagnosing SB Crohns disease Diagnostic yields of 70 have been reported in small series of studies performed in suspected small bowel Crohns disease
This study is designed to determine the yield and clinical impact of Capsule Endoscopy CE in detecting suspected IBD and suspected Crohns Disease of the small bowel when compared to SBFT
While about one half of patients have involvement of the ileum and large bowel another third have disease isolated to the small bowel Frequently small bowel Crohns disease can be difficult to diagnose using the traditional methods of evaluation including colonoscopy with ileoscopy and contrast radiography Mucosal features of Crohns disease are often subtle and difficult to identify by small bowel follow through SBFT The SBFT has traditionally been relied on to evaluate the small intestine for evidence of Crohns disease but it has been shown to have a relatively low accuracy of only 30 This has led to delays in the diagnosis of Crohns disease with reports ranging from one to three years
In the past few years capsule endoscopy has sparked renewed interest in the investigation of IBD and Crohns disease of the small bowel A PillCam SB2 capsule Given Imaging Ltd Yoqneam Israel is an ingestible disposable video camera that transmits high quality images of the small intestinal mucosa This enables the small intestine to be readily accessible to physicians investigating for the presence of small bowel disorders which in the past was inaccessible to physicians A number of small pilot studies demonstrated capsule endoscopy efficacy in diagnosing SB Crohns disease Diagnostic yields of 70 have been reported in small series of studies performed in suspected small bowel Crohns disease
This study is designed to determine the yield and clinical impact of Capsule Endoscopy CE in detecting suspected IBD and suspected Crohns Disease of the small bowel when compared to SBFT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None