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NCT00365534 Clinical Trial

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

Colonoscopy Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00365534
Other study ID # MIC
Secondary ID
Status Withdrawn
Phase N/A
First received August 16, 2006
Last updated March 25, 2010
Start date January 2006

Study information
Verified date March 2010
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• MEI

Locations
Country Name City State
China Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The MEI score difference between regular colonoscopy and CAC.
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