Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Bleeding Ulcers

Inclusion Criteria:

1. Adults age 22 years or older

2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/orhematochezia)

3. Subject voluntarily agrees to participate in the clinical investigation, provideswritten informed consent, and will be able to comply with the investigationalprotocol in the opinion of the site investigator

4. 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 anon-bleeding visible vessel; an esophageal, gastric or duodenal tumor with activebleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesionwith active bleeding or a non-bleeding visible vessel; or an actively bleedingMallory-Weiss tear. The definition of "active oozing" will require bleeding topersist for ≥ 3 minutes of endoscopic observation.

Exclusion Criteria:

1. Incarceration

2. Subjects that are not able to provide written informed consent

3. Pregnancy or nursing mothers

4. Endoscopic hemostatic treatment in the past 30 days

5. Use of triple antithrombotic therapy at the time of presentation

6. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) orendoscopic submucosal dissection (ESD) procedures within the past 2 months

7. Post-polypectomy bleeding

8. Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascularectasia including gastric antral vascular ectasia

9. Platelet count < 50 x 10^9/L

10. INR > 3.5 (or prothrombin time >35 seconds in patient not on warfarin and onlyprothrombin time is provided by local lab), at time of procedure or closest toprocedure time

11. Subjects who have documented galactose intolerance, Lapp lactase deficiency orglucose-galactose malabsorption

12. Subjects with documented hypersensitivity to Brilliant Blue FCF

13. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and thosesuspected or are at high risk of having gastrointestinal perforation.

14. Endoscopy not performed within 36 hours of presentation to hospital/emergencydepartment