Post-polypectomy BleedingNCT01647581
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
A study testing Hemoclip Placement and NO hemoclip placement in people with Post-polypectomy Bleeding and Polypectomy, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-polypectomy Bleeding, Polypectomy, Elective Colonoscopy
- What is being tested?
- Hemoclip Placement and NO hemoclip placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,182 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2011to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for elective colonoscopy
Who cannot join
- Patients in which polypectomy can not be performed safely
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504
About this study
Official title: Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping
A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.
- Conditions
- Post-polypectomy Bleeding, Polypectomy, Elective Colonoscopy
- Being tested
- Hemoclip Placement, NO hemoclip placement
- Keywords
- hemoclip, colonoscopy, post-polypectomy bleed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoclip PlacementDevice
Also called Clip
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
NO hemoclip placementDevice
Also called No Clip
No hemoclip placement (placebo / sham)
| Study group | Role | What they receive |
|---|---|---|
| Clip | Experimental | A clip is been placed at the polypectomy site. Receives: Device: Hemoclip Placement |
| No Clip | Placebo comparator | A hemoclip is not placed at the site of the polypectomy. Receives: Device: NO hemoclip placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Delayed Post Polypectomy Bleeding
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study start1 Sep 2011
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-polypectomy BleedingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11,182 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Linda A Feagins, Principal investigator, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647581
- Sponsor's protocol ID
- CLNB-005-13F
- Other IDs
- DVAMC-11-026
- Status last verified
- Sep 2019
- First submitted
- 19 Jul 2012
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Feagins LA, Smith AD, Kim D, Halai A, Duttala S, Chebaa B, Lunsford T, Vizuete J, Mara M, Mascarenhas R, Meghani R, Kundrotas L, Dunbar KB, Cipher DJ, Harford WV, Spechler SJ. Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps. Gastroenterology. 2019 Oct;157(4):967-976.e1. doi: 10.1053/j.gastro.2019.05.003. Epub 2019 May 31.
PubMed 31158369
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping
- ClinicalTrials.gov ID
- NCT01647581
- Acronym / sponsor ID
- CLNB-005-13F
- Conditions
- Post-polypectomy Bleeding, Polypectomy, Elective Colonoscopy
- Keywords
- hemoclip, colonoscopy, post-polypectomy bleed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,182 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clip | Experimental | Device: Hemoclip PlacementA clip is been placed at the polypectomy site. |
| No Clip | Placebo comparator | Device: NO hemoclip placementA hemoclip is not placed at the site of the polypectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for elective colonoscopy
Key exclusion criteria (1 listed)
- Patients in which polypectomy can not be performed safely
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 |
|---|---|---|
| Hemoclip PlacementAlso: ClipPlacement of hemoclip at polypectomy site for polyps at least 1cm in size | Device | Clip |
| NO hemoclip placementAlso: No ClipNo hemoclip placement (placebo / sham) | Device | No Clip |
Primary outcome
Number of Patients With Delayed Post Polypectomy Bleeding
Time frame: 30 days
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31158369Feagins LA, Smith AD, Kim D, Halai A, Duttala S, Chebaa B, Lunsford T, Vizuete J, Mara M, Mascarenhas R, Meghani R, Kundrotas L, Dunbar KB, Cipher DJ, Harford WV, Spechler SJ. Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps. Gastroenterology. 2019 Oct;157(4):967-976.e1. doi: 10.1053/j.gastro.2019.05.003. Epub 2019 May 31.
- Individual participant dataSharing planned: No
Related trials for Post-polypectomy Bleeding
Active, not recruiting
Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
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RecruitingPhase 3
Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy
Myocardial Infarction (MI), Cardiovascular Events
Not yet recruitingPhase 4
Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial
Bleeding After GI Endoscopy
RecruitingObservational study
Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants
Polyp of Colon
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.
Linda A Feagins principal investigator
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoclip Placement and NO hemoclip placement in people with Post-polypectomy Bleeding and Polypectomy, run by VA Office of Research and Development at 3 sites in United States.
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 1 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Delayed Post Polypectomy Bleeding (time frame: 30 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 NCT01647581, 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 15 Oct 2019.