RecruitingNot ApplicableNCT06188585

Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding

Randomized Controlled Multi-Center Non-Inferiority Trial of UI-EWD (Nexpowder™) vs. Conventional Treatment as First-Line Endoscopic Therapy for Patients With High-Risk Nonvariceal Upper Gastrointestinal Bleeding (TREET)


Sponsor

Medtronic - MITG

Enrollment

278 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute overt gastrointestinal bleeding which is found at endoscopy to be due to 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.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Conventional therapy and a medical device called UI-EWD for people with acute gastrointestinal bleeding. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEUI-EWD

Hemostatic powder administered at index endoscopy

DEVICEConventional therapy

Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy


Locations(14)

Yale

New Haven, Connecticut, United States

RUSH University

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Rutgers University

Piscataway, New Jersey, United States

Northwell Health

Manhasset, New York, United States

NYU Langone

New York, New York, United States

McGill University

Montreal, Quebec, Canada

St. Michael's Hospital

Toronto, Canada

Vancouver General Hospital

Vancouver, Canada

Copenhagen University Hospital

Hvidovre, Denmark

Odense University Hospital

Odense, Denmark

St. Antoine

Paris, France

Emek Medical Center

Afula, Israel

Cleveland Clinic London

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06188585