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NCT06188585 · ClinicalTrials.gov registry record · NA

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

A NA study of Acute Gastrointestinal Bleeding, sponsored by Medtronic - MITG.

Recruiting
Registry status
NA
Development phase
278
Enrollment target
15
Study locations

NCT06188585: Recruiting NA study of Acute Gastrointestinal Bleeding, sponsored by Medtronic - MITG.

NCT06188585 is a NA study of Acute Gastrointestinal Bleeding that is actively recruiting participants, run by Medtronic - MITG. The registered enrollment target is 278 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06188585, a NA study of Acute Gastrointestinal Bleeding, is actively recruiting participants, sponsored by Medtronic - MITG.

RECRUITING
Registry status
NA
Development phase
278 participants
Enrollment target
15
Study locations

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.

Primary Outcome

Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding

Interventions

  • DEVICE UI-EWD
  • DEVICE Conventional therapy

Study Locations (15)

Other

  • St. Michael's Hospital - Toronto
  • Vancouver General Hospital - Vancouver
  • Copenhagen University Hospital - Hvidovre
  • Odense University Hospital - Odense
  • St. Antoine - Paris
  • Emek Medical Center - Afula
  • Cleveland Clinic London - London

New York

  • Northwell Health - Manhasset
  • NYU Langone - New York

Alabama

  • University of Alabama - Birmingham

Connecticut

  • Yale - New Haven

Illinois

  • RUSH University - Chicago

Massachusetts

  • Brigham and Women's Hospital - Boston

New Jersey

  • Rutgers University - Piscataway

Quebec

  • McGill University - Montreal

Trial Details

FieldValue
Enrollment Target 278 participants
Start Date 2024-06-21
Est. Completion 2026-08
Phase NA
Medtronic - MITG

119 total trials

What NCT06188585 shows while recruiting

NCT06188585 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Acute Gastrointestinal Bleeding appearing as the primary indexed condition, and to 2 interventions - of which UI-EWD is the first listed.

NCT06188585 lists 15 locations in 8 states (Other, New York, Alabama).

Frequently Asked Questions

What is clinical trial NCT06188585 about?

NCT06188585 is a clinical study titled "Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding". 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 ...

What is the current status of trial NCT06188585?

This trial is currently recruiting. It is a NA study. The enrollment target is 278 participants. The study started on 2024-06-21. Estimated completion is 2026-08.

What conditions does trial NCT06188585 study?

This clinical trial studies the following conditions: Acute Gastrointestinal Bleeding.

What interventions are being tested in trial NCT06188585?

The interventions under investigation include: UI-EWD (DEVICE), Conventional therapy (DEVICE).

Who is sponsoring clinical trial NCT06188585?

This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06188585 being conducted?

This trial has 15 study locations across Alabama, Connecticut, Illinois, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06188585's enrollment target sits among peer trials

278 382nd of 2000 higher than 1,619 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06188585, the US trial registry maintained by the National Library of Medicine. NCT06188585 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.