UI-EWD vs Conventional Therapy for Gastrointestinal Bleeding

(TREET Trial)

Recruiting at 14 trial locations

Overseen By Bianca Buac

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic - MITG

Must not be taking: Triple antithrombotic therapy

Disqualifiers: Incarceration, Pregnancy, Low platelets, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: During index endoscopy procedure

278 Participants Needed

Trial Summary

What is the purpose of 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 a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using triple antithrombotic therapy at the time of presentation.

What data supports the effectiveness of the treatment UI-EWD for gastrointestinal bleeding?

Research shows that UI-EWD, a hemostatic powder, is effective in stopping bleeding in both upper and lower gastrointestinal areas. It has a high success rate in achieving immediate hemostasis and low rebleeding rates, making it a promising option for treating gastrointestinal bleeding. ^{1 2 3 4 5}

Is UI-EWD safe for use in humans?

UI-EWD, also known as Nexpowder, has been used in studies for treating gastrointestinal bleeding, and no adverse events related to its use were reported, indicating it is generally safe for humans. ^{1 2 3 4 5}

How is the treatment UI-EWD different from other treatments for gastrointestinal bleeding?

UI-EWD is a novel hemostatic powder that can be applied endoscopically to control bleeding in the gastrointestinal tract. It is unique because it forms a muco-adhesive gel that helps stop bleeding quickly and has shown high success rates in preventing re-bleeding, making it a promising option compared to conventional therapies. ^{1 2 3 4 5}

Research Team

Loren Laine, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults 22 or older with acute overt gastrointestinal bleeding, such as vomiting blood or bloody stools. Participants must have a gastric or duodenal ulcer that's actively bleeding, observed for at least 3 minutes during endoscopy. They need to consent and follow the study plan.

Inclusion Criteria

I am 22 years old or older.

I am currently experiencing severe bleeding in my stomach or intestines.

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

Exclusion Criteria

Subject already hospitalized for another condition when UGIB begins

I am unable to give written consent.

I have had a procedure to stop bleeding using an endoscope within the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either UI-EWD hemostatic powder or conventional endoscopic therapy during the index endoscopy procedure

During index endoscopy procedure

1 visit (in-person)

Follow-up

Participants are monitored for further bleeding and other outcomes after treatment

30 days

2 visits (in-person)

Treatment Details

Interventions

• UI-EWD

Trial Overview The trial compares UI-EWD (Nexpowder™), a new hemostatic powder, against conventional therapies in stopping bleeding from gastric or duodenal ulcers. It's a prospective study where patients are randomly assigned to treatments.

Participant Groups

Group I: Test Group Experimental Treatment 1 Intervention

UI-EWD

Group II: Control Group Active Control 1 Intervention

Conventional endoscopic therapy

UI-EWD is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Nexpowder for:

• Non-variceal upper gastrointestinal bleeding

Approved in Canada as Nexpowder for:

• Non-variceal upper gastrointestinal bleeding

Approved in European Union as Nexpowder for:

• Non-variceal upper gastrointestinal bleeding

Who Is Running the Clinical Trial?

Medtronic - MITG

Lead Sponsor

Trials

265

Recruited

301,000+

Geoff Martha

Medtronic - MITG

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. John Doe

Medtronic - MITG

Chief Medical Officer since 2023

MD from Harvard Medical School

North American Science Associates Ltd.

Collaborator

Trials

7

Recruited

920+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Findings from Research

In a study of 41 patients with upper gastrointestinal tumor bleeding, the novel hemostatic powder UI-EWD achieved immediate hemostasis in 97.5% of cases, demonstrating its high efficacy as a treatment option.

UI-EWD showed no associated adverse events and had a re-bleeding rate of 22.5% within 28 days, suggesting it is a safe and effective option for managing gastrointestinal tumor bleeding, either as a salvage therapy or monotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding. Shin, J., Cha, B., Park, JS., et al.[2021]

In a study of 167 patients with acute lower gastrointestinal bleeding, the novel endoscopic hemostatic powder UI-EWD demonstrated a significantly lower re-bleeding rate (5.5%) compared to conventional treatment (17.0%), indicating its efficacy in preventing re-bleeding.

The use of UI-EWD was associated with higher success rates in achieving hemostasis in challenging locations, such as the hepatic flexure and larger lesions, without any recorded adverse events, suggesting it is a safe option for difficult cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemostatic efficacy and safety of the hemostatic powder UI-EWD in patients with lower gastrointestinal bleeding. Cha, B., Lee, D., Shin, J., et al.[2022]

In a study of 17 patients with refractory upper gastrointestinal bleeding, the new hemostatic adhesive powder UI-EWD achieved initial hemostasis in 94% of cases, demonstrating its efficacy as a salvage therapy.

The re-bleeding rate within 30 days was 19% among those who initially achieved hemostasis, indicating that UI-EWD not only effectively stops bleeding but also shows potential in preventing future bleeding episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study. Park, JS., Bang, BW., Hong, SJ., et al.[2020]

In a study of 56 patients with nonvariceal upper gastrointestinal bleeding, the new hemostatic adhesive powder UI-EWD achieved an impressive immediate hemostasis success rate of 96.4%.

The 30-day rebleeding rate was low at 3.7% among those who achieved immediate hemostasis, and no adverse events related to UI-EWD were reported, indicating its safety and efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Park, JS., Kim, HK., Shin, YW., et al.[2020]

The new hemostatic adhesive powder (UI-EWD) was effective in achieving initial hemostasis in all gastric ulcers treated in a study involving eight mini-pigs, indicating its potential as a reliable treatment for acute gastric bleeding.

Follow-up evaluations showed that UI-EWD had significantly lower rates of re-bleeding (10%) compared to the control group (50%) at 6 hours, and it maintained a high level of persistence on ulcer bases over time, suggesting its efficacy and durability in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel endoscopically deliverable muco-adhesive hemostatic powder in an acute gastric bleeding porcine model. Bang, B., Lee, E., Maeng, J., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Hemostatic efficacy and safety of the hemostatic powder UI-EWD in patients with lower gastrointestinal bleeding. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a novel endoscopically deliverable muco-adhesive hemostatic powder in an acute gastric bleeding porcine model. [2020]