Colonic PolypsNCT02205125
Cold Polypectomy Site Study
An observational study of Colonic Polyps, run by Professor Michael Bourke at 1 site in Australia.
Trial summary
Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colonic Polyps
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2013to Dec 2013
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colonoscopy at a tertiary endoscopy unit.
Who may be able to join
- Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned.
Who cannot join
- Age < 18 years
- Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).
Trial locations and contacts
1 site in 1 country.
Australia1 site
Westmead Hospital Endoscopy Unit
Sydney, New South Wales, 2145
About this study
Official title: Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy
Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. This study aims to separately sample the irregular area and determine the constituents while recording how frequently this occurs during routine colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue and do not represent polyp tissue left behind.
- Conditions
- Colonic Polyps
- Keywords
- polyp, colon, polypectomy, snare
- Medical subject headings
- Colonic Polyps, Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and constituents of stalk projections in cold snare polypectomy sites
Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, MBBS, FRACP, Principal investigator, WSLHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205125
- Sponsor's protocol ID
- HREC2013/8/6.6(3797)
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2014
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy
- ClinicalTrials.gov ID
- NCT02205125
- Acronym / sponsor ID
- HREC2013/8/6.6(3797)
- Conditions
- Colonic Polyps
- Keywords
- polyp, colon, polypectomy, snare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jul 2014 (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.
Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. This study aims to separately sample the irregular area and determine the constituents while recording how frequently this occurs during routine colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue and do not represent polyp tissue left behind.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colonoscopy at a tertiary endoscopy unit.
Key inclusion criteria (1 listed)
- Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned.
Key exclusion criteria (2 listed)
- Age < 18 years
- Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).
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
Frequency and constituents of stalk projections in cold snare polypectomy sites
Time frame: 14 days
Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
Michael Bourke, MBBS, FRACP principal investigator
WSLHD
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 Colonic Polyps, run by Professor Michael Bourke at 1 site in Australia.
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 2 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: finished, as of the sponsor's last update on 23 Mar 2021. 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency and constituents of stalk projections in cold snare polypectomy sites (time frame: 14 days). 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 23 Mar 2021.