Comparing UI-EWD with Conventional therapy for acute gastrointestinal bleeding
Official title: Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
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)
- 2 groups
- Sites in Toronto, Vancouver and 1 more city
- Recruiting
Interventions
- Medical device
UI-EWD
Hemostatic powder administered at index endoscopy
- Medical device
Conventional therapy
Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
McGill University
Montreal, Quebec
- Recruiting
St. Michael's Hospital
Toronto
- Recruiting
Vancouver General Hospital
Vancouver
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, and will be able to comply with the investigational protocolProtocolThe detailed plan a study must follow.Read more → in the opinion of the siteTrial siteA hospital or clinic where a study is actually run.Read more → investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- +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
- −Subjects with documented hypersensitivity to Brilliant Blue FCF
- −Incarceration
- −Subjects that are not able to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −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 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
- −Pregnancy or nursing mothers
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives UI-EWD.
Registry label: A: Test Group
Group B, the comparison group, receives Conventional therapy.
Registry label: B: Control Group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 22 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 278 people.
The study is currently expected to finish around September 2029.
The main measurement is taken over: 7 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
No further bleeding during the 7-day period after hemostatic treatment — measured over 7 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06188585 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About UI-EWDDevice
Hemostatic powder administered at index endoscopy
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Conventional therapyDevice
Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 22 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 22 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 7 days.
The study as a whole is currently expected to finish around 2029-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 278 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Toronto, Canada; Vancouver, Canada; Montreal, Quebec, Canada; Manhasset, New York, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (2)
Northwell Health
Manhasset, New York, United States
NYU Langone
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.