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Powder could replace needles and clips for stomach bleeds

NCT ID NCT06188585

Disease control Sponsor: Medtronic - MITG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new hemostatic powder, Nexpowder™, to standard treatments (like clips, heat, or injections) for stopping high-risk bleeding in the upper digestive tract. About 278 adults with active bleeding from ulcers, tumors, or tears will be randomly assigned to one of the two approaches. The main goal is to see if the powder works as well as standard therapy in preventing further bleeding within 7 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nexpowder™ (hemostatic powder)
What this could lead to
If successful, this could offer a simpler, equally effective first-line treatment for serious upper gastrointestinal bleeding, potentially reducing the need for more complex procedures.
What could go wrong
This is a non-inferiority trial, meaning it only aims to show the powder is not worse than standard care, not that it is better. The study is still recruiting, and results may not apply to all bleeding types.

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

About 278 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 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: 1. Adults age 22 years or older 2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia) 3. Subject voluntarily agrees to participate in the clinical investigation, provides written informed consent, and will be able to comply with the investigational protocol in the opinion of the site investigator 4. Cause of bleeding as determined at upper endoscopy is one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear. The definition of "active oozing" will require bleeding to persist for ≥ 3 minutes of endoscopic observation. Exclusion Criteria: 1. Incarceration 2. Subjects that are not able to provide written informed consent 3. Pregnancy or nursing mothers 4. Endoscopic hemostatic treatment in the past 30 days 5. Use of triple antithrombotic therapy at the time of presentation 6. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months 7. Post-polypectomy bleeding 8. Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia 9. Platelet count \< 50 x 10\^9/L 10. INR \> 3.5 (or prothrombin time \>35 seconds in patient not on warfarin and only prothrombin time is provided by local lab), at time of procedure or closest to procedure time 11. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 12. Subjects with documented hypersensitivity to Brilliant Blue FCF 13. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation. 14. Endoscopy not performed within 36 hours of presentation to hospital/emergency department

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Conditions

The condition(s) this trial relates to.

Gastrointestinal Hemorrhage peptic ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute gastrointestinal bleeding

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic London

    RECRUITING

    London, United Kingdom

  • Copenhagen University Hospital

    RECRUITING

    Hvidovre, Denmark

  • Emek Medical Center

    RECRUITING

    Afula, Israel

  • McGill University

    RECRUITING

    Montreal, Quebec, Canada

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Odense University Hospital

    RECRUITING

    Odense, Denmark

  • RUSH University

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Rutgers University

    RECRUITING

    Piscataway, New Jersey, 08901, United States

  • St. Antoine

    RECRUITING

    Paris, France

  • St. Michael's Hospital

    RECRUITING

    Toronto, Canada

  • Vancouver General Hospital

    RECRUITING

    Vancouver, Canada

  • Yale

    RECRUITING

    New Haven, Connecticut, 06520, United States