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

NCT06188585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • Acute Gastrointestinal Bleeding

Interventions

DEVICE

UI-EWD

Hemostatic powder administered at index endoscopy

DEVICE

Conventional therapy

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

Sponsors & Collaborators

  • North American Science Associates Ltd.

    collaborator NETWORK

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Loren Laine, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Israel
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188585 on ClinicalTrials.gov