Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Recruiting
N/A
Interventional Study
Acute Gastrointestinal Bleeding
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 278 (estimated)
- Sponsor
- Medtronic - MITG · Industry
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About This Trial
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 oozin…
Trial Locations
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Eligibility Criteria
Inclusion 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 th…
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