Status:
RECRUITING
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Lead Sponsor:
Medtronic - MITG
Collaborating Sponsors:
North American Science Associates Ltd.
Conditions:
Acute Gastrointestinal Bleeding
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 p...
Detailed Description
Endoscopic hemostatic therapy is recommended as the first line therapy for patients with upper gastrointestinal bleeding (UGIB) due to ulcers with active bleeding or a non-bleeding visible vessel iden...
Eligibility Criteria
Inclusion
- Adults age 22 years or older
- Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)
- 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
- 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
- Incarceration
- Subjects that are not able to provide written informed consent
- Pregnancy or nursing mothers
- Endoscopic hemostatic treatment in the past 30 days
- Use of triple antithrombotic therapy at the time of presentation
- Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
- Post-polypectomy bleeding
- Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia
- Platelet count \< 50 x 10\^9/L
- 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
- Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects with documented hypersensitivity to Brilliant Blue FCF
- Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
- Endoscopy not performed within 36 hours of presentation to hospital/emergency department
Key Trial Info
Start Date :
June 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT06188585
Start Date
June 21 2024
End Date
August 1 2026
Last Update
September 23 2025
Active Locations (15)
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1
University of Alabama
Birmingham, Alabama, United States, 35205
2
Yale
New Haven, Connecticut, United States, 06520
3
RUSH University
Chicago, Illinois, United States, 60612
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115