An interventional study of Doppler Endoscopic Probe in Delayed Post-Polypectomy Induced Ulcer Hemorrhage, sponsored by VA Office of Research and Development. Active, not recruiting at 3 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
VA Central Office recently opened back research study after suspension from March to Sept 2020 with COVID 19
Severe delayed post-polypectomy induced ulcer (PPIU) bleeding has become a much more common problem with the increased numbers of colonoscopies being performed and with more patients taking anti-coagulants or anti-platelet drugs. Current medical guidelines may reduce bleeding during polypectomy, but are not effective for prevention of delayed bleeding. Empiric closure of PPIU's with clips is not effective because ulcers > 15 mm cannot be closed, does not treat the underlying artery in the ulcer base, and when the clips often fall off within 7 the underlying artery is exposed. As preliminary results, the investigators studied delayed PPIU bleeds and their prevention, used a Doppler endoscopic probe (DEP) to localize arteries in PPIU's, reported the prevalence which rises significantly as ulcer size increases, and successfully obliterated blood flow with focal treatment. These studies form the basis for this new RCT. The primary specific aim is to perform a 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. Secondary specific aims are to evaluate the natural history and risk factors for delayed PPIU bleeding using univariate and multivariable analyses. This is a RCT performed by the CURE Hemostasis Research Group for high risk patients - those with PPIU's 15 mm in size or greater but not on drugs associated with bleeding; or patients who require anti-coagulants or anti-platelet drugs for treatment of co-morbid conditions and have PPIU's 10 mm or larger. Outpatients, scheduled for screening or surveillance colonoscopies, who give written informed consent and meet entry criteria will be randomized to control/no DEP (medical treatment without PPIU closure) or DEP (as a guide to arterial blood flow detection and focal obliteration of it with hemoclips and/or low power multipolar electrocautery [MPEC] probe). Patients will be prospectively followed at 7, 14, and 30 days for bleeding, complications, or unscheduled visits for healthcare after polypectomies.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Ambulatory patients, 35 years old or more and who are having:
Clinically the patient has to have a medical indication and recommendation by their primary care physician (PCP) or specialist to take:
On colonoscopy, they are required to have:
Exclusion Criteria:
Intrinsic bleeding disorder with a history of recurrent bleeding either after:
Recurrent rectal bleeding from another chronic colorectal condition such as:
For Standard treatment group, the Doppler probe will not be used, nor will hemoclip closure of post-polypectomy ulcers be attempted. Standard published guidelines will be followed for management of blood thinners (anti-coagulants) and/or aspirin like drugs (anti-platelet drugs) before and after the colonoscopic polypectomies. This is the standard of care at the investigators' medical centers and part of written instructions that are given to the participants and their referring physicians during the scheduling process and prior to their preparation for screening or surveillance outpatient colonoscopies.
Device: Doppler Endoscopic Probe
A colon length catheter (probe) will be used to check the non-bleeding post-polypectomy ulcer with shallow and medium depth Doppler probe settings (\< 4 mm deep) for arterial blood flow. If arterial flow is found, treatment through the colonoscope (either hemoclipping or multipolar electrocoagulation probe) will be used to stop the arterial flow. This will be confirmed by rechecking with Doppler probe after endoscopic treatment. Tatoos (Spot method) will be placed on two sides of the ulcer so treated.
Device: Doppler Endoscopic Probe
A colon length catheter (probe).
The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.
We will compare the proportion of participants with PPIU bleeding by 30 days follow up in Doppler endoscopic probe (DEP) versus standard treatment. The p value for testing this hypothesis will be computed using Fisher's exact test. The corresponding 95% confidence bounds for the true difference will also be reported.
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled.
The proportion of participants hospitalized.
We will compare the proportion of participants hospitalized for PPIU bleeds or other complications at 30 days, the number of participants in DEP group and standard group overall. Fisher's exact test will be used to compare the proportion hospitalized for PPIU bleeding by 30 days in DEP versus standard.
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled.
The total number of hospitalized days.
We will determine if number of hospitalized days follows a count distribution such as the Poisson or Negative Binomial distribution or if the log total hospital days follows a normal or other parametric distribution. We will therefore use the appropriate count model, t test or non parametric test (Wilcoxon rank sum) to compare the number of days hospitalized distribution in DEP versus standard as well as report the corresponding descriptive statistics (n, range, quartiles, median, mean, SD, frequencies) and histogram.
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled.
The proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized
Comparison of proportion of participants with rectal bleeding reported to us but not severe enough to be hospitalized. Fisher's exact test will be used to compare the proportion with this type of rectal bleeding after polypectomy up to 30 days after enrollment in the DEP versus standard treatment groups.
Time frame: Outcome measure will be assessed up to 30 days after enrollment
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development