Active — Not RecruitingNot Applicable

Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding

United States180 participantsStarted 2017-02-15

Plain-language summary

The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps.

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ambulatory patients, 35 years old or more and who are having: * elective, outpatient screening * surveillance colonoscopy for colon cancer or polyps * or being evaluated for abdominal pain or change in bowel habits ---or have a large polyp needing removal by EMR or ESD * Clinically the patient has to have a medical indication and recommendation by their primary care physician (PCP) or specialist to take: * daily anti-coagulants (Warfarin, low-molecular-weight heparin \[LMWH\] or a newer agent) * or an anti-platelet drug (aspirin as 81 mg or more, Clopidogrel, or newer agents) for PPIU's 10-14mm * or if not on one of these drugs, they must have a PPIU 15 mm * On colonoscopy, they are required to have: * benign appearing polyps and for 1 or more PPIU to be 10 mm in size (for the anti-coagulant or anti-platelet groups) * or 15 mm or larger for the PPIU group who do not have to be (but may be) on these drugs that can induce bleeding * In the case of bleeding from the PPIU during polypectomy, hemorrhage must be completely controlled Exclusion Criteria: * Inability or unwillingness to give written informed consent or to return to the investigators' medical centers for follow-up (FU) in the next 30 days, in case of delayed bleeding or other complications * Intrinsic bleeding disorder with a history of recurrent bleeding either after: * surgeries * angiography * or other invasive procedures * Significantly abnormal coagulation tests …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.

Timeframe: Outcome measure will be assessed at 30 days after participants are enrolled.

Trial details

NCT IDNCT02875353

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Delayed Post-Polypectomy Induced Ulcer Hemorrhage trials