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

Recruiting now · Not applicable

Conditions studied: Acute Gastrointestinal Bleeding

In brief

A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute overt gastrointestinal bleeding which is found at endoscopy to be due to 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.

Key facts

Study ID

NCT06188585

Run by

Medtronic - MITG

People needed

278

Starts

2024-06-21

Expected to finish

2029-09-01

Last updated by the study team

2026-06-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale — New Haven, Connecticut, United States (enrolling)
• RUSH University — Chicago, Illinois, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Rutgers University — Piscataway, New Jersey, United States (enrolling)
• Northwell Health — Manhasset, New York, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• McGill University — Montreal, Quebec, Canada (enrolling)
• St. Michael's Hospital — Toronto, Canada (enrolling)
• Vancouver General Hospital — Vancouver, Canada (enrolling)
• Copenhagen University Hospital — Hvidovre, Denmark (enrolling)
• Odense University Hospital — Odense, Denmark (enrolling)
• St. Antoine — Paris, France (enrolling)
• Emek Medical Center — Afula, Israel (enrolling)
• Cleveland Clinic London — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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