Actively Recruiting
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Led by Medtronic - MITG · Updated on 2025-09-23
278
Participants Needed
15
Research Sites
110 weeks
Total Duration
On this page
Sponsors
M
Medtronic - MITG
Lead Sponsor
N
North American Science Associates Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 22 years or older
- Presentation with acute overt gastrointestinal bleeding such as hematemesis, melena, or hematochezia
- Voluntary agreement to participate with written informed consent and ability to comply with the study protocol
- Bleeding source identified by upper endoscopy as gastric or duodenal ulcer with active bleeding or non-bleeding visible vessel; esophageal, gastric or duodenal tumor with active bleeding or non-bleeding visible vessel; gastric or duodenal Dieulafoy lesion with active bleeding or non-bleeding visible vessel; or actively bleeding Mallory-Weiss tear
- Active oozing defined as bleeding lasting at least 3 minutes during endoscopic observation
You will not qualify if you...
- Incarceration
- Unable to provide written informed consent
- Pregnancy or nursing mothers
- Endoscopic hemostatic treatment within the past 30 days
- Use of triple antithrombotic therapy at the time of presentation
- Gastric or duodenal endoscopic mucosal resection or endoscopic submucosal dissection within the past 2 months
- Post-polypectomy bleeding
- Erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia
- Platelet count less than 50 x 10^9/L
- INR greater than 3.5 or prothrombin time over 35 seconds if not on warfarin
- Documented galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Documented hypersensitivity to Brilliant Blue FCF
- Suspected bowel obstruction, gastrointestinal fistulas, or high risk of gastrointestinal perforation
- Endoscopy not performed within 36 hours of hospital or emergency department presentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of Alabama
Birmingham, Alabama, United States, 35205
Active, Not Recruiting
2
Yale
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
RUSH University
Chicago, Illinois, United States, 60612
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Rutgers University
Piscataway, New Jersey, United States, 08901
Actively Recruiting
6
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
7
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
8
McGill University
Montreal, Quebec, Canada
Actively Recruiting
9
St. Michael's Hospital
Toronto, Canada
Actively Recruiting
10
Vancouver General Hospital
Vancouver, Canada
Actively Recruiting
11
Copenhagen University Hospital
Hvidovre, Denmark
Actively Recruiting
12
Odense University Hospital
Odense, Denmark
Actively Recruiting
13
St. Antoine
Paris, France
Actively Recruiting
14
Emek Medical Center
Afula, Israel
Actively Recruiting
15
Cleveland Clinic London
London, United Kingdom
Actively Recruiting
Research Team
G
Geraldine Kelly
CONTACT
K
Kara Saddoris
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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