Colonic PolypsCuRBNCT02196649
Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial
A study testing Endoscopic Clip in people with Colonic Polyps, run by Professor Michael Bourke at 1 site in Australia.
Trial summary
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Endoscopic Clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2014to 1 Mar 2021
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can give informed consent to trial participation
- Lesion size greater than 20 mm
- Lesion proximal to and inclusive of mid transverse colon
- Laterally spreading or sessile polyp morphology
Who cannot join
- Previous resection or attempted resection of lesion
- Clip deployed prior to the completion of the EMR
- Major intraprocedural bleeding not treatable by coagulation
- Endoscopic appearance of invasive malignancy
- Age less than 18 years
- Pregnancy
Show all 9Show fewer
- Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
- Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
- American Society of Anesthesiology (ASA) Grade IV-V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.
Read the detailed description
The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.
- Conditions
- Colonic Polyps
- Being tested
- Endoscopic Clip
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ClipDevice
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Clipping | Experimental | Participants randomised to the arm will receive endoscopic clips to their defect following EMR. Receives: Device: Endoscopic Clip |
| No Endoscopic Clipping | No intervention | These participants will receive standard of care practice only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Procedural Bleeding
Clinically significant post colonic wide-field EMR bleeding (CSPEB)
Measured: 14 days
Secondary outcomes (1)
Safety success
Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startOct 2014
- Primary completion1 Dec 2020
- Study completion1 Mar 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 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 J Bourke, MBBS, Principal investigator, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196649
- Sponsor's protocol ID
- HREC2014/5/4.2(3971)
- Acronym
- CuRB
- Status last verified
- Mar 2025
- First submitted
- 17 Jul 2014
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF, Zahid S, Whitfield A, Byth K, Brown G, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18.
PubMed 34801133
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02196649
- Acronym / sponsor ID
- CuRB / HREC2014/5/4.2(3971)
- Conditions
- Colonic Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 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.
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.
Detailed description
The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Clipping | Experimental | Device: Endoscopic ClipParticipants randomised to the arm will receive endoscopic clips to their defect following EMR. |
| No Endoscopic Clipping | No intervention | –These participants will receive standard of care practice only. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Can give informed consent to trial participation
- Lesion size greater than 20 mm
- Lesion proximal to and inclusive of mid transverse colon
- Laterally spreading or sessile polyp morphology
Key exclusion criteria (9 listed)
- Previous resection or attempted resection of lesion
- Clip deployed prior to the completion of the EMR
- Major intraprocedural bleeding not treatable by coagulation
- Endoscopic appearance of invasive malignancy
- Age less than 18 years
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 |
|---|---|---|
| Endoscopic Clip | Device | Endoscopic Clipping |
Primary outcome
Post-Procedural Bleeding
Time frame: 14 days
Clinically significant post colonic wide-field EMR bleeding (CSPEB)
1 secondary outcome
Safety success
Time frame: 18 months
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 27 Mar 2025.
- Derived from this study: PubMed 34801133Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF, Zahid S, Whitfield A, Byth K, Brown G, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18.
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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 J Bourke, MBBS principal investigator
Western Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Clip in people with 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 4 inclusion and 9 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 27 Mar 2025. 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?
Post-Procedural Bleeding (time frame: 14 days). 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 NCT02196649, 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 27 Mar 2025.