Comparing a new hemostatic powder to standard treatment for bleeding ulcers
Randomized Controlled Multi-Center Non-Inferiority Trial of UI-EWD (Nexpowder™) vs. Conventional Treatment as First-Line Endoscopic Therapy for Patients With High-Risk Nonvariceal Upper Gastrointestinal Bleeding (TREET)
This study is testing a new hemostatic powder to see if it works as well as standard treatment for adults with bleeding ulcers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 278 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Medtronic - MITG Industry-sponsored |
| Locations | 15 sites (Birmingham, Alabama and 14 other locations) |
| Trial ID | NCT06188585 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, noninferiority randomized controlled trial that aims to evaluate the effectiveness of UI-EWD hemostatic powder (Nexpowder™) compared to conventional endoscopic hemostatic therapy in patients with acute gastrointestinal bleeding due to gastric or duodenal ulcers. Participants will be adults presenting with active bleeding or a non-bleeding visible vessel identified during endoscopy. The study will assess the primary outcome of hemostasis and rebleeding rates between the two treatment approaches. The trial is designed to provide insights into whether the new powder can serve as an effective first-line therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 22 years or older who present with acute overt gastrointestinal bleeding due to gastric or duodenal ulcers.
Not a fit: Patients who are pregnant, nursing, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with acute gastrointestinal bleeding, potentially reducing rebleeding rates.
How similar studies have performed: Previous studies have shown promising results with UI-EWD hemostatic powder, indicating that this approach may be effective, though this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Birmingham, Alabama and 14 other locations
- University of Alabama — Birmingham, Alabama, United States (Active_not_recruiting)
- Yale — New Haven, Connecticut, United States (Recruiting)
- RUSH University — Chicago, Illinois, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Rutgers University — Piscataway, New Jersey, United States (Recruiting)
- Northwell Health — Manhasset, New York, United States (Recruiting)
- NYU Langone — New York, New York, United States (Recruiting)
- McGill University — Montreal, Quebec, Canada (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)
Study contacts
- Study coordinator: Geraldine Kelly
- Email: geraldine.kelly@medtronic.com
- Phone: +353014393000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.