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New probe aims to stop post-polypectomy bleeding in high-risk patients

NCT ID NCT02875353

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

180 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

35 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Kaiser Permanente-Downey Medical Center

    Downey, California, 90242, United States

  • University of California, Los Angeles, Ronald Reagan Medical Center

    Los Angeles, California, 90095, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073-1003, United States