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

Study acronym: TREET
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jul 2026 to Aug 2029
    • Study sites: 15 to 14
    • Study completion date: Aug 2026 to Sep 2029
    v13
  2. Site details revised at 1 of 15 sitesv12
  3. Site details revised at 2 of 15 sites
    • Study title expanded, about 2 words
    v11
  4. Eligibility criteria expanded, about 52 words
    • Secondary endpoints revised (4)
    • Site details revised at 1 of 15 sites
    • Study description expanded, about 2 words
    v10
  5. Site details revised at 2 of 15 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 1 of 15 sitesv8
  2. Eligibility criteria revised
    • Site details revised at 4 of 15 sites
    v7
  3. Study sites: 13 to 15v6
  4. Study sites: 10 to 13
    • Collaborator revised
    v5
  5. Site details revised at 2 of 10 sitesv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 10
    • Start date changed from estimate of May 2024 to Jun 21, 2024
    v3
  7. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06188585
Lead Sponsor Medtronic - MITG
Collaborators: North American Science Associates Ltd.
Conditions
(from sponsor)		 Acute Gastrointestinal Bleeding
Related terms Gastrointestinal Hemorrhage, Peptic Ulcer
Enrollment 278 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov