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

NCT06188585 | Recruiting DMC FDA Device

• 1 other identifier: MDT23013
• Study Type: interventional
• Target: 278
• Locations: 6 countries
• Sites: 15

Brief 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.

Conditions

Acute Gastrointestinal Bleeding

Keywords

Gastrointestinal hemorrhage; Peptic Ulcer; Nonvariceal upper gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• No further bleeding during the 7-day period after hemostatic treatment

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

  7 days

Secondary Outcomes (4)

• Composite 30-day outcome of further bleeding

  30 days

• Initial hemostasis for patients with active bleeding at randomization

  During index endoscopy procedure

• Number of participants with recurrent bleeding over the 7-day period after randomization

  7 days

• Mortality

  30 days

Study Arms (2)

Test Group

EXPERIMENTAL

UI-EWD

Device: UI-EWD

Control Group

ACTIVE COMPARATOR

Conventional endoscopic therapy

Device: Conventional therapy

Interventions

UI-EWD DEVICE

Hemostatic powder administered at index endoscopy

Also known as: Nexpowder™

Test Group

Conventional therapy DEVICE

Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy

Also known as: Bipolar electrocoagulation or Bipolar electrocoagulation endoscopic hemostasis, Epinephrine (1:10,000 dilution) injection or Endoscopic hemostatic injection of epinephrine (1:10,000 dilution), Endoscopic hemostatic clip, Argon plasma coagulation

Control Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 22 years or older
• Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)
• 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
• 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.

You may not qualify if:

• Incarceration
• Subjects that are not able to provide written informed consent
• Pregnancy or nursing mothers
• Endoscopic hemostatic treatment in the past 30 days
• Use of triple antithrombotic therapy at the time of presentation
• Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
• Post-polypectomy bleeding
• Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia
• Platelet count \< 50 x 10\^9/L
• 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
• Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Subjects with documented hypersensitivity to Brilliant Blue FCF
• Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
• Endoscopy not performed within 36 hours of presentation to hospital/emergency department

Sponsors & Collaborators

• Medtronic - MITG: lead
• North American Science Associates Ltd.: collaborator

Study Sites (15)

University of Alabama

Birmingham, Alabama, 35205, United States

ACTIVE NOT RECRUITING

Yale

New Haven, Connecticut, 06520, United States

RECRUITING

RUSH University

Chicago, Illinois, 60612, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Rutgers University

Piscataway, New Jersey, 08901, United States

RECRUITING

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

NYU Langone

New York, New York, 10016, 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

Related Publications (3)

• Park JS, Kim HK, Shin YW, Kwon KS, Lee DH. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767. doi: 10.1055/a-0982-3194. Epub 2019 Dec 10.

  PMID: 31828214 BACKGROUND

• Cha B. A Randomized Control Study Evaluating the Efficacy of a Hemostatic Powder (UI-EWD) in Decreasing the Rate of Upper Gastrointestinal Re-Bleeding in Patients Treated with Endoscopic Therapy for High-Risk Lesions. Oral presentation presented at: Digestive Disease Week 2023; May 9, 2023; Chicago, IL.

  BACKGROUND

• Al Alawi S, Bessissow T, Fallone CA, Jacques J, Barkun A. Hemostatic powder's battle against a spurting bleeding ulcer: can it win? Endoscopy. 2025 Dec;57(S 01):E676-E677. doi: 10.1055/a-2610-3096. Epub 2025 Jun 26. No abstract available.

  PMID: 40570926 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Peptic Ulcer

Interventions

Indicator Dilution Techniques; Injections; Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Drug Administration Routes; Drug Therapy; Therapeutics; Electrocoagulation; Cautery; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Officials

• Loren Laine, MD

  Yale University

  STUDY CHAIR

Central Study Contacts

Geraldine Kelly

CONTACT

+353014393000; geraldine.kelly@medtronic.com

Kara Saddoris

CONTACT

303-476-7598; kara.l.saddoris@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned with concealed allocation in a 1:1 ratio to receive treatment with UI-EWD hemostatic powder (Nexpowder) or conventional endoscopic hemostatic therapy (defined as bipolar electrocoagulation or clips or argon plasma coagulation with or without epinephrine injection therapy).

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); FR (1); IL (1); CA (3); DK (2); GB (1)