ColonoscopyCACNCT01126632
Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial
An observational study of Colonoscopy, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Jan 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endoscopy Clinic- Patients already receiving colonoscopies
Who may be able to join
- Patients already booked for a colonoscopy
Who cannot join
- History of Colorectal Cancer
- Severe colitis
- Cancer
- poor bowel prep
Trial locations and contacts
1 site in 1 country.
About this study
Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.
Read the detailed description
To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cap Assisted Colonoscopy | Patients receiving colonoscopies where scope is fitted with cap | |
| Standard Colonoscopy | Patients receiving standard colonoscopy without the cap on the scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
cap-assisted colonoscopy compared visibility with standard colonoscopy
Propose to perform a randomized controlled trial comparing cap-assisted colonoscopy with the standard colonoscopy to assess visibility. To see if it is easier to detect polyps, adenomas with the cap than without. This is standard procedure. Just comparing if it is better to use the cap during colonoscopy.
Measured: 4 months
Secondary outcomes (7)
Polyp detection rate
Number of Polyps detected per procedure using the cap. To see if it is more visible.
Measured: 4 months
Adenoma Detection
number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap.
Measured: 4 months
Advanced lesion detection rate
(number of advanced lesions per procedure) defined as lesions with high-grade dysplasia, greater than 1 cm. size. To see if it is more visible using the cap as to not using the cap.
Measured: 4 months
Cecal Intubation Rate
Time to cecum
Measured: 4 months
Total time for colonoscopy
Measured: 4 months
Complication Rate
Amount of complications during colonoscopies
Measured: 4 months
Procedure indication
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Caps became unavailable by manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald G MacIntosh, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126632
- Sponsor's protocol ID
- CAC Study
- Acronym
- CAC
- Status last verified
- Jan 2016
- First submitted
- 15 May 2010
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study was terminated
Publications
Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
PubMed 19098847
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01126632
- Acronym / sponsor ID
- CAC / CAC Study
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Caps became unavailable by manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 May 2010 (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.
Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.
Detailed description
To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap Assisted Colonoscopy | – | –Patients receiving colonoscopies where scope is fitted with cap |
| Standard Colonoscopy | – | –Patients receiving standard colonoscopy without the cap on the scope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endoscopy Clinic- Patients already receiving colonoscopies
Key inclusion criteria (1 listed)
- Patients already booked for a colonoscopy
Key exclusion criteria (4 listed)
- History of Colorectal Cancer
- Severe colitis
- Cancer
- poor bowel prep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cap-assisted colonoscopy compared visibility with standard colonoscopy
Time frame: 4 months
Propose to perform a randomized controlled trial comparing cap-assisted colonoscopy with the standard colonoscopy to assess visibility. To see if it is easier to detect polyps, adenomas with the cap than without. This is standard procedure. Just comparing if it is better to use the cap during colonoscopy.
7 secondary outcomes
Polyp detection rate
Time frame: 4 months
Adenoma Detection
Time frame: 4 months
Advanced lesion detection rate
Time frame: 4 months
Cecal Intubation Rate
Time frame: 4 months
Total time for colonoscopy
Time frame: 4 months
Complication Rate
Time frame: 4 months
Procedure indication
Time frame: 4 months
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 28 Jan 2016.
- Results publication: PubMed 19098847Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
- Individual participant dataSharing planned: No. Study was terminated
Related trials for Colonoscopy
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
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.
Donald G MacIntosh, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 4 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 28 Jan 2016. 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 Canada. 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?
cap-assisted colonoscopy compared visibility with standard colonoscopy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126632, which also lists 1 linked publication.
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 28 Jan 2016.