Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding

Inclusion Criteria

• 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 Criteria

• 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