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

Launched by MEDTRONIC - MITG · Dec 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called UI-EWD (Nexpowder™), which is a hemostatic powder designed to help stop bleeding from ulcers in the stomach or the first part of the small intestine. Researchers want to see if this new powder is as effective as the standard treatment currently used during endoscopy, a procedure where doctors look inside the digestive tract. The trial is open to adults aged 22 and older who are experiencing acute gastrointestinal bleeding, which can show up as vomiting blood or passing black, tarry stools.

To participate, individuals must agree to be part of the study and be diagnosed with active bleeding from a gastric or duodenal ulcer during an endoscopy. However, certain people may not qualify, such as those who are pregnant, have certain medical conditions, or have had recent treatments for similar issues. Participants will receive either the new powder or the standard treatment during their procedure, and the goal is to find out which method works better in stopping the bleeding. This trial is currently recruiting, so if you or someone you know is experiencing these symptoms and might be interested, it could be a good opportunity to help advance medical knowledge in this area.

Gender

ALL

Eligibility 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