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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  22 and up

Participation 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 the investigational protocol in the opinion of the site investigator
4. Cause of bleeding as determined at endoscopy is gastric or duodenal ulcer bleeding with active spurting or oozing bleeding or a non-bleeding visible vessel. The definition of "active oozing" will require bleeding to persist for ≥ 3 minutes of endoscopic 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) or endoscopic 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 only prothrombin time is provided by local lab), at time of procedure or closest to procedure time
10. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
11. Subjects with documented hypersensitivity to Brilliant Blue FCF
12. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
13. Endoscopy not performed within 30 hours of presentation