Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434551
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2007-02-11
Brief Title:
MACCS Multicenter Australian CE in Patients With Suspected Crohns Disease Study
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohns Disease
Status:
COMPLETED
Status Verified Date:
2007-02
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:
MACCS
Brief Summary:
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohns disease in symptomatic patients who have a non-diagnostic standard workup Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment Patients will be followed up for up to 3 months after capsule endoscopy
Detailed Description:
In the past few years capsule endoscopy has sparked renewed interest in the investigation of small bowel Crohns disease A PillCamSB 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 such as Crohns disease It has been demonstrated that capsule endoscopy identifies Crohns disease when other methods are not helpful 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 accuracy and clinical impact of Capsule Endoscopy in detecting suspected small Bowel Crohns Disease whose initial evaluation was non-diagnostic It will also serve to better understand the impact of capsule endoscopy on the natural history of the disorder
Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment This will allow assessment of the natural history of this form of Crohns disease and ensure that any changes in CDAI and QOL after capsule endoscopy are not merely a result of this natural history
This study is designed to determine the accuracy and clinical impact of Capsule Endoscopy in detecting suspected small Bowel Crohns Disease whose initial evaluation was non-diagnostic It will also serve to better understand the impact of capsule endoscopy on the natural history of the disorder
Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment This will allow assessment of the natural history of this form of Crohns disease and ensure that any changes in CDAI and QOL after capsule endoscopy are not merely a result of this natural history
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