Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
NCT ID: NCT06188585
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
278 participants
INTERVENTIONAL
2024-06-21
2026-08-31
Brief Summary
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Detailed Description
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UI-EWD hemostatic powder (Nexpowder™), which is manufactured by NextBiomedical and distributed by Medtronic, is approved for treatment of nonvariceal GI bleeding in the U.S., Canada, European Union and other countries.
A retrospective study of UI-EWD hemostatic powder in 56 patients with active bleeding found immediate hemostasis in 54 (96.4%), with rebleeding within 7 days in only 2 patients (3.7%)\[1\]. A large multi-center randomized trial in 340 patients with nonvariceal UGIB and either active bleeding or a non-bleeding visible vessel compared conventional endoscopic hemostatic therapy alone to conventional therapy plus UI-EWD. Rebleeding was significantly lower in the UI-EWD group at 3 days (3 vs. 11%) and at 30 days (19% vs. 7%) \[2\].
The primary aim of this trial is to demonstrate that UI-EWD when used as initial hemostatic therapy is non-inferior to older conventional endoscopic hemostatic therapy for the treatment of patients with high-risk nonvariceal upper GI bleeding.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Group
UI-EWD
UI-EWD
Hemostatic powder administered at index endoscopy
Control Group
Conventional endoscopic therapy
Conventional therapy
Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
Interventions
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UI-EWD
Hemostatic powder administered at index endoscopy
Conventional therapy
Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
ALL
No
Sponsors
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North American Science Associates Ltd.
NETWORK
Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Loren Laine, MD
Role: STUDY_CHAIR
Yale University
Locations
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University of Alabama
Birmingham, Alabama, United States
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
Countries
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Central Contacts
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Facility Contacts
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Kenneth Hung, M.D.
Role: primary
Neal Mehta, M.D.
Role: primary
Linda Lee, MD
Role: primary
Arvind Trindade, M.D.
Role: primary
Juan Bucobo, M.D.
Role: primary
Melissa Debordeaux, M.D.
Role: primary
Yen-I Chen, M.D.
Role: primary
John G Karstensen
Role: primary
Marine Camus, M.D.
Role: primary
Halim Awadie
Role: primary
Rehan Haidry, M.D.
Role: primary
References
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Park JS, Kim HK, Shin YW, Kwon KS, Lee DH. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767. doi: 10.1055/a-0982-3194. Epub 2019 Dec 10.
Cha B. A Randomized Control Study Evaluating the Efficacy of a Hemostatic Powder (UI-EWD) in Decreasing the Rate of Upper Gastrointestinal Re-Bleeding in Patients Treated with Endoscopic Therapy for High-Risk Lesions. Oral presentation presented at: Digestive Disease Week 2023; May 9, 2023; Chicago, IL.
Al Alawi S, Bessissow T, Fallone CA, Jacques J, Barkun A. Hemostatic powder's battle against a spurting bleeding ulcer: can it win? Endoscopy. 2025 Dec;57(S 01):E676-E677. doi: 10.1055/a-2610-3096. Epub 2025 Jun 26. No abstract available.
Other Identifiers
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MDT23013
Identifier Type: -
Identifier Source: org_study_id
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