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Clinical Trials in the UK / NCT06188585
Recruiting Not applicable

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

NCT06188585 · tracked via the Priya Life Science UK tracker
Sponsor
Medtronic - MITG
Phase
Not applicable
Started
2024-06-21
Last updated
2026-06-22

Condition(s) studied

Acute Gastrointestinal Bleeding

Investigational drug(s) / intervention(s)

UI-EWDConventional therapy

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

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
No
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 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. Exclusion Criteria: 1. Incarceration 2. Subjects that are not able to provide written informed consent 3. Pregnancy or nursing mothers 4. Endoscopic hemostatic treatment in the past 30 days 5. Use of triple antithrombotic therapy at the time of presentation 6. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months 7. Post-polypectomy bleeding 8. Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia 9. Platelet count \< 50 x 10\^9/L 10. 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 11. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 12. Subjects with documented hypersensitivity to Brilliant Blue FCF 13. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation. 14. Endoscopy not performed within 36 hours of presentation to hospital/emergency department

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
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

More Medtronic - MITG trials in the UK

Official registry record

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 the UK