Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Bleeding Ulcers

Acute Gastrointestinal Bleeding Clinical Trial

— TREET  

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 Bleeding Ulcers (TREET)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06188585
• Other study ID #: MDT23013
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2026

Study information

• Verified date: December 2023
• Source: Medtronic - MITG
• Contact: Ana Vieira
• Phone: 754.261.5572
• Email: ana.vieira[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel.

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 UGIB 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 peptic ulcer bleeding.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 278
• Est. completion date: August 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Adults age 22 years or older

2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and/or hematochezia)

3. 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

4. Cause of bleeding as determined at endoscopy is gastric or duodenal ulcer bleeding with active spurting or oozing bleeding or a non-bleeding visible vessel. The definition of "active oozing" will require bleeding to persist for = 3 minutes of endoscopic observation.

Exclusion Criteria:

1. Incarceration

2. Subjects that are not able to provide written informed consent

3. Subject already hospitalized for another condition when UGIB begins

4. Pregnancy or nursing mothers

5. Endoscopic hemostatic treatment in the past 30 days

6. Use of triple antithrombotic therapy at the time of presentation

7. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months

8. Platelet count < 50 x 109/L

9. 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

10. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

11. Subjects with documented hypersensitivity to Brilliant Blue FCF

12. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.

13. Endoscopy not performed within 30 hours of presentation

Related Conditions & MeSH terms

• Acute Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• UI-EWD
Hemostatic powder administered at index endoscopy
• Conventional therapy
Conventional endoscopic therapy (bipolar electrocoagulation or clips, with or without epinephrine injection) administered at index endoscopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic - MITG	NAMSA

References & Publications (2)

Cha 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Secondary	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)	30 days
Secondary	Number of participants with active bleeding (Forrest 1a/1b) at randomization who have initial hemostasis with study-assigned endoscopic therapy	Initial hemostasis with study-assigned endoscopic therapy for patients with actively bleeding ulcers (Forrest Ia and Ib) at randomization	During index endoscopy procedure
Secondary	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	7 days
Secondary	Mortality	30-day mortality	30 days