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New treatment option for Acute Gastrointestinal Bleeding
Official title Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
ClinicalTrials.gov ID: NCT06188585
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join 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...
- Cause of bleeding as determined at upper endoscopy is one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or...
You likely can't join if
- Incarceration
- people 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
- people who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2...
See the full eligibility criteria
- 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...
- Incarceration
- people 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
- people who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
- Post-polypectomy bleeding
- people 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
- people who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- people with documented hypersensitivity to Brilliant Blue FCF
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Piscataway, New Jersey, United States
- Manhasset, New York, United States
- New York, New York, United States
- Montreal, Quebec, Canada
- Toronto, Canada
- Vancouver, Canada
- Hvidovre, Denmark
- Odense, Denmark
- Paris, France
- Afula, Israel
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Piscataway, New Jersey, United States; Manhasset, New York, United States; New York, New York, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.