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

Conditions

• Acute Gastrointestinal Bleeding

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 21, 2024

Status verified

Jul 2025

Primary completion

Jul 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

278 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Test Group
  UI-EWD
• Active Comparator: Control Group
  Conventional endoscopic therapy

Primary Outcome Measure

No further bleeding during the 7-day period after hemostatic treatment [ Time Frame: 7 days ]

Central Contacts

• Geraldine Kelly
  +353014393000
  [email protected]
• Kara Saddoris
  303-476-7598
  [email protected]

Locations (7)

Find similar trials in Birmingham, AL