Acute Gastrointestinal BleedingTREETNCT06188585
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
A study testing UI-EWD and Conventional therapy in people with Acute Gastrointestinal Bleeding, run by Medtronic - MITG at 14 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Gastrointestinal Bleeding
- What is being tested?
- UI-EWD and Conventional therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 21 Jun 2024to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Who cannot join
- Incarceration
- Subjects 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
- Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months
Show all 14Show fewer
- 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 documented hypersensitivity to Brilliant Blue FCF
- 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
Trial locations and contacts
14 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 6 countries
United States6 sites, 6 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Linda Lee, MD
Linda Lee, MD
- Recruiting
RUSH University
Chicago, Illinois, 60612
Neal Mehta, M.D.
Neal Mehta, M.D.
- Recruiting
Northwell Health
Manhasset, New York, 11030
Juan Bucobo, M.D.
Juan Bucobo, M.D.
- Recruiting
Yale
New Haven, Connecticut, 06520
Kenneth Hung, M.D.
Kenneth Hung, M.D.
- Recruiting
NYU Langone
New York, New York, 10016
Melissa Debordeaux, M.D.
Melissa Debordeaux, M.D.
- Recruiting
Rutgers University
Piscataway, New Jersey, 08901
Arvind Trindade, M.D.
Arvind Trindade, M.D.
Canada3 sites, 3 recruiting
- Recruiting
McGill University
Montreal, Quebec
Yen-I Chen, M.D.
Yen-I Chen, M.D.
- Recruiting
St. Michael's Hospital
Toronto
Jeffrey Mosko, MD, MSc, FRCPC
- Recruiting
Vancouver General Hospital
Vancouver
Roberto Trasolini, MD
Denmark2 sites, 2 recruiting
- Recruiting
Copenhagen University Hospital
Hvidovre
John G Karstensen
John G Karstensen
- Recruiting
Odense University Hospital
Odense
Stig Laursen, MD, PhD
France1 site, 1 recruiting
- Recruiting
St. Antoine
Paris
Marine Camus, M.D.
Marine Camus, M.D.
Israel1 site, 1 recruiting
- Recruiting
Emek Medical Center
Afula
Halim Awadie
Halim Awadie
United Kingdom1 site, 1 recruiting
- Recruiting
Cleveland Clinic London
London
Rehan Haidry, M.D.
Rehan Haidry, M.D.
About this study
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)
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.
Read the 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 GI bleeding 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 nonvariceal upper GI bleeding.
- Conditions
- Acute Gastrointestinal Bleeding
- Being tested
- UI-EWD, Conventional therapy
- Keywords
- Gastrointestinal hemorrhage, Peptic Ulcer, Nonvariceal upper gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI-EWDDevice
Also called Nexpowder™
Hemostatic powder administered at index endoscopy
Conventional therapyDevice
Also called 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, Argon plasma coagulation
Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | UI-EWD Receives: Device: UI-EWD |
| Control Group | Active comparator | Conventional endoscopic therapy Receives: Device: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
No further bleeding during the 7-day period after hemostatic treatment
Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding
Measured: 7 days
Secondary outcomes (4)
Composite 30-day outcome of further bleeding
Further bleeding leading to red blood cell transfusion or urgent intervention (need for alternative therapy at index endoscopy, repeat endoscopy, interventional radiology, or surgery)
Measured: 30 days
Initial hemostasis for patients with active bleeding at randomization
Initial hemostasis with study-assigned endoscopic therapy for patients with active bleeding
Measured: During index endoscopy procedure
Number of participants with recurrent bleeding over the 7-day period after randomization
Recurrent bleeding among all patients with hemostasis within 7 days after study-assigned endoscopic therapy
Measured: 7 days
Mortality
30-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start21 Jun 2024
- Primary completionAug 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned with concealed allocation in a 1:1 ratio to receive treatment with UI-EWD hemostatic powder (Nexpowder) or conventional endoscopic hemostatic therapy (defined as bipolar electrocoagulation or clips or argon plasma coagulation with or without epinephrine injection therapy).
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Responsible party
- Sponsor
- Investigators
- Loren Laine, MD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188585
- Sponsor's protocol ID
- MDT23013
- Acronym
- TREET
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Park JS, Kim HK, Shin YW, Kwon KS, Lee DH. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767. doi: 10.1055/a-0982-3194. Epub 2019 Dec 10.
PubMed 31828214Cha B. A Randomized Control Study Evaluating the Efficacy of a Hemostatic Powder (UI-EWD) in Decreasing the Rate of Upper Gastrointestinal Re-Bleeding in Patients Treated with Endoscopic Therapy for High-Risk Lesions. Oral presentation presented at: Digestive Disease Week 2023; May 9, 2023; Chicago, IL.
Al Alawi S, Bessissow T, Fallone CA, Jacques J, Barkun A. Hemostatic powder's battle against a spurting bleeding ulcer: can it win? Endoscopy. 2025 Dec;57(S 01):E676-E677. doi: 10.1055/a-2610-3096. Epub 2025 Jun 26. No abstract available.
PubMed 40570926
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06188585
- Acronym / sponsor ID
- TREET / MDT23013
- Conditions
- Acute Gastrointestinal Bleeding
- Keywords
- Gastrointestinal hemorrhage, Peptic Ulcer, Nonvariceal upper gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 GI bleeding 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 nonvariceal upper GI bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned with concealed allocation in a 1:1 ratio to receive treatment with UI-EWD hemostatic powder (Nexpowder) or conventional endoscopic hemostatic therapy (defined as bipolar electrocoagulation or clips or argon plasma coagulation with or without epinephrine injection therapy).
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: UI-EWDUI-EWD |
| Control Group | Active comparator | Device: Conventional therapyConventional endoscopic therapy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 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.
Key exclusion criteria (14 listed)
- Incarceration
- Subjects 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UI-EWDAlso: Nexpowder™Hemostatic powder administered at index endoscopy | Device | Test Group |
| Conventional therapyAlso: 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, Argon plasma coagulationConventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy | Device | Control Group |
Primary outcome
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
4 secondary outcomes
Composite 30-day outcome of further bleeding
Time frame: 30 days
Initial hemostasis for patients with active bleeding at randomization
Time frame: During index endoscopy procedure
Number of participants with recurrent bleeding over the 7-day period after randomization
Time frame: 7 days
Mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 31828214Park JS, Kim HK, Shin YW, Kwon KS, Lee DH. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767. doi: 10.1055/a-0982-3194. Epub 2019 Dec 10.
- BackgroundCha B. A Randomized Control Study Evaluating the Efficacy of a Hemostatic Powder (UI-EWD) in Decreasing the Rate of Upper Gastrointestinal Re-Bleeding in Patients Treated with Endoscopic Therapy for High-Risk Lesions. Oral presentation presented at: Digestive Disease Week 2023; May 9, 2023; Chicago, IL.
- Derived from this study: PubMed 40570926Al Alawi S, Bessissow T, Fallone CA, Jacques J, Barkun A. Hemostatic powder's battle against a spurting bleeding ulcer: can it win? Endoscopy. 2025 Dec;57(S 01):E676-E677. doi: 10.1055/a-2610-3096. Epub 2025 Jun 26. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loren Laine, MD study chair
Yale University
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UI-EWD and Conventional therapy in people with Acute Gastrointestinal Bleeding, run by Medtronic - MITG at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Denmark, France, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geraldine Kelly (+353014393000, geraldine.kelly@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No further bleeding during the 7-day period after hemostatic treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.