Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Bleeding Ulcers (TREET)

January 3, 2024 updated by: Medtronic - MITG

Randomized Controlled Multi-Center Non-Inferiority Trial of UI-EWD (Nexpowder™) vs. Conventional Treatment as First-Line Endoscopic Therapy for Patients With High-Risk Bleeding Ulcers (TREET)

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 a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 UGIB 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 peptic ulcer bleeding.

Study Type

Interventional

Enrollment (Estimated)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults age 22 years or older
  2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)
  3. 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
  4. Cause of bleeding as determined at endoscopy is gastric or duodenal ulcer bleeding with active spurting or oozing bleeding or a non-bleeding visible vessel. The definition of "active oozing" will require bleeding to persist for ≥ 3 minutes of endoscopic observation.

Exclusion Criteria:

  1. Incarceration
  2. Subjects that are not able to provide written informed consent
  3. Subject already hospitalized for another condition when UGIB begins
  4. Pregnancy or nursing mothers
  5. Endoscopic hemostatic treatment in the past 30 days
  6. Use of triple antithrombotic therapy at the time of presentation
  7. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
  8. Platelet count < 50 x 109/L
  9. 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
  10. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  11. Subjects with documented hypersensitivity to Brilliant Blue FCF
  12. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
  13. Endoscopy not performed within 30 hours of presentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
UI-EWD
Device: UI-EWD
Hemostatic powder administered at index endoscopy
Other Names:
  • Nexpowder™
Active Comparator: Control Group
Conventional endoscopic therapy
Device: Conventional therapy
Conventional endoscopic therapy (bipolar electrocoagulation or clips, with or without epinephrine injection) administered at index endoscopy
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No further bleeding during the 7-day period after hemostatic treatment
Time Frame: 7 days
Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30-day mortality
30 days
Composite 30-day outcome of further bleeding
Time Frame: 30 days
Further bleeding leading to red blood cell transfusion or urgent intervention (need for alternative therapy at index endoscopy, repeat endoscopy, interventional radiology, or surgery)
30 days
Number of participants with active bleeding (Forrest 1a/1b) at randomization who have initial hemostasis with study-assigned endoscopic therapy
Time Frame: During index endoscopy procedure
Initial hemostasis with study-assigned endoscopic therapy for patients with actively bleeding ulcers (Forrest Ia and Ib) at randomization
During index endoscopy procedure
Number of participants with recurrent bleeding over the 7-day period after randomization
Time Frame: 7 days
Recurrent bleeding among all patients with hemostasis within 7 days after study-assigned endoscopic therapy
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Collaborators

NAMSA

Investigators

  • Study Chair: Loren Laine, MD, Yale School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT23013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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