Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure

This study is currently recruiting participants.

Verified by Chinese University of Hong Kong, April 2006

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00365534

Purpose

The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.

Condition	Intervention
Colonoscopy	Procedure: MEI

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blinded Randomized Study Comparison the Mechanism of Looping Formation and Subject's Acceptance During CAC and Regular Colonoscopy by MEI (MIC Study)

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

The MEI score difference between regular colonoscopy and CAC.

Estimated Enrollment:	20
Study Start Date:	July 2006

Detailed Description:

Colonoscopy is widely used for the investigation of lower gastrointestinal tract disease.However,colonoscopy remains a technically difficult procedure. As the colon is a mobile organ, looping may occur when the colonoscope passes through.Hence,reducing looping during procedure is very improtant to achieve succes as well as patient acceptance.Recently,some studies shown that cap-assisted colonoscopy(CAC)allow better visualisation of the colonic folds, thus increase success rate.However, previous studies shown that magnetic endoscope imaging (MEI)is useful as an adjunct to assist endoscopist in performing the procedure and as a modality to look for the mechanism of looping. Because of such concern,our study is to compare the mechanism of looping formation and acceptance of CAC and regular colonoscopy by MEI.

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Patient undergo first colonoscopy examination
Signed informed consent

Exclusion Criteria:

Patient had received colonoscopy examination before.
Patient had prior colorectal surgery done(apart from appendectomy)
Known to have colonic stricture or obstructing tumour from the result of other investigations such as CT scan or barium enema.
Presence of acute surgical conditions such as severe colitis, megacolon, ischaemic colitis and active gastrointestinal bleeding.
Patient could not provide consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365534

Contacts

Contact: Yuk Tong Lee, MD

852 2632 3131

leeytong@cuhk.edu.hk

Locations

China
Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital	Recruiting
Hong Kong, China
Contact: Yuk Tong Lee, MD 852 2632 3131 leeytong@cuhk.edu.hk

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Yuk Tong Lee, MD

Chinese University of Hong Kong

More Information

Study ID Numbers:	MIC
Study First Received:	August 16, 2006
Last Updated:	August 16, 2006
ClinicalTrials.gov Identifier:	NCT00365534
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

First colonoscopy examination

ClinicalTrials.gov processed this record on January 14, 2009