Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Condition(s) studied
Investigational drug(s) / intervention(s)
UI-EWD: Hemostatic powder administered at index endoscopy
Conventional therapy: Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
Study summary
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.
Eligibility
Primary outcome measure(s)
- No further bleeding during the 7-day period after hemostatic treatment — 7 days
Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale | New Haven | Connecticut | Recruiting |
| RUSH University | Chicago | Illinois | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Rutgers University | Piscataway | New Jersey | Recruiting |
| Northwell Health | Manhasset | New York | Recruiting |
| NYU Langone | New York | New York | Recruiting |
| McGill University | Montreal | Quebec | Recruiting |
| St. Michael's Hospital | Toronto | Canada | Recruiting |
| Vancouver General Hospital | Vancouver | Canada | Recruiting |
| Copenhagen University Hospital | Hvidovre | Denmark | Recruiting |
| Odense University Hospital | Odense | Denmark | Recruiting |
| St. Antoine | Paris | France | Recruiting |
| Emek Medical Center | Afula | Israel | Recruiting |
| Cleveland Clinic London | London | United Kingdom | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06188585 on ClinicalTrials.gov ↗ ← All trials in Denmark