RECRUITING

Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Bleeding Ulcers

Description

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.

Conditions

Acute Gastrointestinal Bleeding
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Related Conditions:

Acute Gastrointestinal Bleeding

Study Overview

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Study Details

Study overview

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.

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)

Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Bleeding Ulcers

Condition
Acute Gastrointestinal Bleeding
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35205

New Haven

Yale, New Haven, Connecticut, United States, 06520

Chicago

RUSH University, Chicago, Illinois, United States, 60612

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Piscataway

Rutgers University, Piscataway, New Jersey, United States, 08901

Manhasset

Northwell Health, Manhasset, New York, United States, 11030

New York

NYU Langone, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic - MITG,

Loren Laine, MD, STUDY_CHAIR, Yale University

Study Record Dates

2026-08