NCT06188585

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Endoscopic hemostatic therapy is recommended as the first line therapy for patients with upper gastrointestinal bleeding (UGIB) due to ulcers with active bleeding or a non-bleeding visible vessel identified at endoscopy. A variety of endoscopic modalities are used in the treatment of UGIB, including thermal therapies (e.g., bipolar electrocoagulation), injection therapy (e.g., epinephrine), clips, and hemostatic powder spray. Topical therapies, such as hemostatic powder spray, have been the most recent addition to the armamentarium of endoscopic therapies for UGIB. UI-EWD hemostatic powder (Nexpowder™), which is manufactured by NextBiomedical and distributed by Medtronic, is approved for treatment of nonvariceal GI bleeding in the U.S., Canada, European Union and other countries. A retrospective study of UI-EWD hemostatic powder in 56 patients with active bleeding found immediate hemostasis in 54 (96.4%), with rebleeding within 7 days in only 2 patients (3.7%)\[1\]. A large multi-center randomized trial in 340 patients with nonvariceal UGIB and either active bleeding or a non-bleeding visible vessel compared conventional endoscopic hemostatic therapy alone to conventional therapy plus UI-EWD. Rebleeding was significantly lower in the UI-EWD group at 3 days (3 vs. 11%) and at 30 days (19% vs. 7%) \[2\]. The primary aim of this trial is to demonstrate that UI-EWD when used as initial hemostatic therapy is non-inferior to older conventional endoscopic hemostatic therapy for the treatment of patients with high-risk nonvariceal upper GI bleeding.

Conditions

• Acute Gastrointestinal Bleeding

Interventions

Type	Name	Description
DEVICE	UI-EWD	Hemostatic powder administered at index endoscopy
DEVICE	Conventional therapy	Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-01-03
• Last updated: 2025-09-23

Locations

15 sites across 6 countries: United States, Canada, Denmark, France, Israel, United Kingdom

Regulatory

• FDA-regulated device study