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.
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.
Incarceration
Subjects that are not able to provide written informed consent
Pregnancy or nursing mothers
Endoscopic hemostatic treatment in the past 30 days
Parallel
UI-EWD
DeviceHemostatic powder administered at index endoscopy
Conventional therapy
DeviceConventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
No further bleeding during the 7-day period after hemostatic treatment
Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding
Composite 30-day outcome of further bleeding
Further bleeding leading to red blood cell transfusion or urgent intervention (need for alternative therapy at index endoscopy, repeat endoscopy, interventional radiology, or surgery)
Initial hemostasis for patients with active bleeding at randomization
Initial hemostasis with study-assigned endoscopic therapy for patients with active bleeding
Number of participants with recurrent bleeding over the 7-day period after randomization
Recurrent bleeding among all patients with hemostasis within 7 days after study-assigned endoscopic therapy
Mortality
30-day mortality
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Medtronic - MITG
Lead sponsor
North American Science Associates Ltd.
Collaborator
