ColonoscopyNCT00365534
Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure
A study testing MEI in people with Colonoscopy, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonoscopy
- What is being tested?
- MEI
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patient undergo first colonoscopy examination
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital
Hong Kong
About this 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)
The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.
Read the 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.
- Conditions
- Colonoscopy
- Being tested
- MEI
- Keywords
- First colonoscopy examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEIProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The MEI score difference between regular colonoscopy and CAC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startJan 2006
Why it stopped: The study was incorporated in another study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Yuk Tong Lee, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365534
- Sponsor's protocol ID
- MIC
- Status last verified
- Mar 2010
- First submitted
- 16 Aug 2006
- Last updated
- 26 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00365534
- Acronym / sponsor ID
- MIC
- Conditions
- Colonoscopy
- Keywords
- First colonoscopy examination
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was incorporated in another study.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergo first colonoscopy examination
- Signed informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEI | Procedure or surgery | – |
Primary outcome
The MEI score difference between regular colonoscopy and CAC.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuk Tong Lee, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEI in people with Colonoscopy, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MEI score difference between regular colonoscopy and CAC.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2010.