New probe aims to stop post-polypectomy bleeding in high-risk patients
NCT ID NCT02875353
First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study tests a special probe that checks blood flow in ulcers left after colon polyp removal. The goal is to see if using this probe to guide treatment can prevent delayed bleeding, especially in patients taking blood thinners or with large polyps. About 180 high-risk adults will be randomly assigned to either standard care or probe-guided care, and bleeding rates will be compared over 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Doppler endoscopic probe (a device that detects blood flow)
- What this could lead to
- If successful, this device could become a standard tool to prevent dangerous delayed bleeding after colon polyp removal, especially for patients on blood thinners.
- What could go wrong
- This is a relatively small, early-stage trial (180 participants) and the device may not reduce bleeding rates significantly compared to standard care. The procedure also carries its own minor risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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180 people
The number who actually took part.
- Started
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Feb 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 related to co-morbid liver, hematologic, or infectious disorders and not anti-coagulant drugs, with platelet count \< 100,000; international normalized ratio (INR) \> 1.5; or partial thromboplastin time (PTT) more than 1.5 times normal * Inflammatory bowel disease * Infectious colitis * Idiopathic colitis with a history of recurrent rectal bleeding * Recurrent rectal bleeding from another chronic colorectal condition such as: * colonic angiomas * radiation colitis * proctitis * or internal hemorrhoids * A sessile polyp that can not be raised up by saline injection or Endoscopic mucosal resection (EMR) techniques nor completely removed by snare polypectomy either en block or in pieces and there is a suspicion about possible malignancy by the colonoscopist. * Recently colonoscopy (within less than 3 years) unless the patient is referred for a large or multiple polyps (on more recent colonoscopy) and colonoscopic removal in the investigators' referral centers
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kaiser Permanente-Downey Medical Center
Downey, California, 90242, United States
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University of California, Los Angeles, Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
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VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003, United States