UI-EWD vs Conventional Therapy for Gastrointestinal Bleeding

(TREET Trial)

Recruiting at 15 trial locations

Overseen By Kara Saddoris

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hemostatic powder called UI-EWD (Nexpowder™) to determine its effectiveness compared to the usual endoscopic treatment for stopping bleeding in the stomach or upper intestines. It targets individuals with sudden and obvious bleeding from ulcers, tumors, or specific tears or lesions in these areas. Those who have experienced visible bleeding through vomiting or in their stool and have had an endoscopy showing bleeding from these sources might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that UI-EWD (Nexpowder™) is safe for treating bleeding in the stomach and intestines. Studies have found it to be highly effective in stopping bleeding, with high success rates. One study reported a 97% success rate when used for ulcers and tumors.

Patients who previously used UI-EWD experienced good results, particularly in hard-to-reach areas. This suggests that it is well-tolerated and effective for many individuals. While every treatment carries risks, the available data indicate that UI-EWD is generally safe and effective for managing difficult bleeding in the stomach and intestines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The treatment UI-EWD for gastrointestinal bleeding is unique because it offers a novel approach compared to conventional endoscopic therapies. Unlike standard methods, which primarily focus on mechanical intervention, UI-EWD may incorporate advanced technology or innovative techniques to enhance precision and effectiveness. Researchers are excited about this treatment because it has the potential to improve outcomes, reduce recovery times, or offer a less invasive option for patients, setting it apart from the conventional therapies currently in use.

What evidence suggests that this trial's treatments could be effective for gastrointestinal bleeding?

This trial will compare UI-EWD (Nexpowder™) with conventional endoscopic therapy for gastrointestinal bleeding. Studies have shown that UI-EWD effectively stops bleeding in the upper digestive system. In one study, it successfully stopped bleeding in 96.8% of patients. Another study found it effective for all treated patients, with only 5.5% to 8.5% experiencing recurrent bleeding within 30 days. These results suggest that UI-EWD is a promising option for managing digestive system bleeding. It appears especially useful in hard-to-reach areas and could serve as a reliable alternative to traditional methods. ^{1 2 4 5 6}

Who Is on the Research Team?

Loren Laine, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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

I am unable to give written consent.

Subject already hospitalized for another condition when UGIB begins

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. giejournal.org giejournal.org/article/S0016-5107(25)01345-8/fulltext

MULTICENTER STUDY OF SAFETY AND EFFICACY ... Conclusions. Nexpowder is a safe and effective treatment for upper gastrointestinal bleeding with high rates of immediate hemostasis, low rates ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8991611/

Hemostatic efficacy and safety of the hemostatic powder UI ... Based on our results, application of UI-EWD in LGIB showed promising results for the prevention of re-bleeding, especially in locations where it is difficult ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/00365521.2024.2403120

UI-EWD hemostatic powder in the management of ... Hemostasis by non-contact thermal therapy showed success in all patients, however, the 30-day rebleeding rate was high up to 33%, based on ...

4. e-ce.org e-ce.org/journal/view.php?number=7851

Current status and clinical outcome of endoscopic ... In the current study, the clinical success rate of UI-EWD for upper GI bleeding was 96.8%, consistent with a previous single-center study of UI- ...

5. ijgii.org ijgii.org/journal/view.html?uid=520&vmd=Full

Topical hemostatic powders in the management of ... Initial hemostasis was successful in all patients treated with Nexpowder, with rebleeding rates of 5.5% (3/55) and 8.5% (5/59) within 30-day ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06269588

Efficacy and Safety of Nexpowder™ for Non-variceal ... Inclusion Criteria: Males or females aged over 21 to 75 years; Patients with confirmed nonvariceal, upper gastrointestinal bleeding; Patients ...