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 endoscopy is gastric or duodenal ulcer bleedingwith active spurting or oozing bleeding or a non-bleeding visible vessel. Thedefinition of "active oozing" will require bleeding to persist for ≥ 3 minutes ofendoscopic observation.

Exclusion Criteria:

1. Incarceration

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

3. Subject already hospitalized for another condition when UGIB begins

4. Pregnancy or nursing mothers

5. Endoscopic hemostatic treatment in the past 30 days

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

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

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

9. 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

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

11. Subjects with documented hypersensitivity to Brilliant Blue FCF

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

13. Endoscopy not performed within 30 hours of presentation