Comparing a new hemostatic powder to standard treatment for bleeding ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-center, noninferiority randomized controlled trial that aims to evaluate the effectiveness of UI-EWD hemostatic powder (Nexpowder™) compared to conventional endoscopic hemostatic therapy in patients with acute gastrointestinal bleeding due to gastric or duodenal ulcers. Participants will be adults presenting with active bleeding or a non-bleeding visible vessel identified during endoscopy. The study will assess the primary outcome of hemostasis and rebleeding rates between the two treatment approaches. The trial is designed to provide insights into whether the new powder can serve as an effective first-line therapy.

Why it matters

Who can join: the full rules

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 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.

Exclusion Criteria:

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

Where it's running

• Yale
  New Haven, Connecticut, United States Recruiting
• RUSH University
  Chicago, Illinois, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Rutgers University
  Piscataway, New Jersey, United States Recruiting
• Northwell Health
  Manhasset, New York, United States Recruiting
• NYU Langone
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Geraldine Kelly
• Email: geraldine.kelly@medtronic.com
• Phone: +353014393000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.