RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-21
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06188585

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults age 22 years or older
  2. 2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)
  3. 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. 4. 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.
  1. 1. Incarceration
  2. 2. Subjects that are not able to provide written informed consent
  3. 3. Pregnancy or nursing mothers
  4. 4. Endoscopic hemostatic treatment in the past 30 days
  5. 5. Use of triple antithrombotic therapy at the time of presentation
  6. 6. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
  7. 7. Post-polypectomy bleeding
  8. 8. Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia
  9. 9. Platelet count \< 50 x 10\^9/L
  10. 10. 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
  11. 11. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  12. 12. Subjects with documented hypersensitivity to Brilliant Blue FCF
  13. 13. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.
  14. 14. Endoscopy not performed within 36 hours of presentation to hospital/emergency department

Contacts and Locations

Study Contact

Bianca Buac
CONTACT
5104323544
bianca.b.buac@medtronic.com
Amber Eruchalu
CONTACT
720.357.1169
amber.eruchalu@medtronic.com

Principal Investigator

Loren Laine, MD
STUDY_CHAIR
Yale University

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35205
United States
Yale
New Haven, Connecticut, 06520
United States
RUSH University
Chicago, Illinois, 60612
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Rutgers University
Piscataway, New Jersey, 08901
United States
Northwell Health
Manhasset, New York, 11030
United States
NYU Langone
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

  • Loren Laine, MD, STUDY_CHAIR, Yale University

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 Registration Dates

Study Start Date2024-06-21
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-06-21
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Gastrointestinal hemorrhage
  • Peptic Ulcer
  • Nonvariceal upper gastrointestinal bleeding

Additional Relevant MeSH Terms

  • Acute Gastrointestinal Bleeding