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.
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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…
Contacts

Geraldine Kelly

+353014393000

geraldine.kelly@medtronic.com

CONTACT

Kara Saddoris

303-476-7598

kara.l.saddoris@medtronic.com

CONTACT