RecruitingNAINTERVENTIONAL

Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding

This study is looking at a new treatment called UI-EWD (Nexpowder™), which is a special powder used to stop bleeding inside your stomach or upper gut. Doctors are comparing it to the usual ways they stop bleeding. They want to see if this powder treatment works just as well as the standard methods for patients who have fresh, active bleeding from problems like stomach ulcers, growths, or other specific conditions in the upper digestive tract. The study is important because it could offer another effective way to manage these serious bleeding episodes, helping patients recover faster and reduce the chances of bleeding coming back.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic - MITG

Enrolment target

278

Start

21 Jun 2024

Estimated completion

01 Aug 2026

Acute Gastrointestinal Bleeding

What is this study about?

This study is looking into new ways to treat serious bleeding in your upper digestive system, which includes your food pipe (oesophagus), stomach, and the first part of your small intestine (duodenum). Sometimes, problems like stomach ulcers, specific growths, or tears can cause fresh bleeding that doctors need to stop quickly.

Currently, doctors use various methods during an endoscopy – a procedure where a thin, flexible tube with a camera is put down your throat – to treat these bleeds. These can include using heat, injections, or small clips. More recently, a special powder spray has also been introduced. This study is focusing on one such powder, called UI-EWD (also known as Nexpowder™).

Nexpowder™ is already used in many countries. Previous studies have suggested it's very good at stopping bleeding quickly and might even help prevent future bleeding. The main goal of this particular study is to find out if using Nexpowder™ as the first treatment for these serious bleeds is as good as, or not significantly worse than, the older, more traditional methods. It’s important to find effective treatments so patients can recover well and avoid further complications.

Key takeaways

The study compares a new powder treatment (Nexpowder™) with current standard treatments for internal bleeding.
It focuses on serious bleeding in the upper digestive system, like from ulcers or growths.
The main goal is to see if Nexpowder™ works just as well as other established methods.
Patients in the study will receive either the powder or standard treatment.
This research aims to improve how doctors stop active bleeding and prevent it from returning.
You must be an adult aged 22 or over with specific types of bleeding to participate.

Who may be eligible?

To join this study, you need to be an adult, aged 22 or older, and currently experiencing fresh bleeding in your digestive system that doctors discover during an endoscopy. This bleeding must be coming from specific issues like an ulcer, a growth, or a tear in your stomach or the first part of your small intestine.

There are also reasons why you might not be able to join. For example, if you've recently had another treatment for bleeding in the same area within the last month, or if you're taking a special combination of three blood-thinning medicines. You also can't take part if you're pregnant or breastfeeding, have certain severe blood conditions, or cannot give your permission to be in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 22 years old or older?
Are you currently experiencing fresh bleeding in your upper digestive system?
Is your bleeding caused by an ulcer, growth, or tear found during an endoscopy?
Are you not pregnant or breastfeeding?
Have you not had a recent similar bleeding treatment in the last month?
Are you able to agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new Nexpowder™ treatment or one of the standard endoscopic treatments for your bleeding. Doctors would monitor your condition closely during your hospital stay and after you go home. This would involve follow-up appointments and checks to see how well the treatment worked and if the bleeding has stopped or returned. All procedures and follow-up care would be explained in detail before you agree to take part, and the total length of your involvement in the study would depend on your recovery, but likely involve initial hospital care and follow-up visits.

Potential risks and benefits

Taking part in a study like this could offer you access to a potentially effective new treatment for your bleeding. While all medical procedures carry some risks, the doctors will carefully monitor you. Potential risks are generally similar to those for standard endoscopy with treatment, such as a small chance of infection or complications from the procedure. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama
Verified postcode
Birmingham, United States· Active not recruiting
Yale
Verified postcode
New Haven, United States· Recruiting
RUSH University
Verified postcode
Chicago, United States· Recruiting
Brigham and Women's Hospital
Verified postcode
Boston, United States· Recruiting
Rutgers University
Verified postcode
Piscataway, United States· Recruiting
Northwell Health
Verified postcode
Manhasset, United States· Recruiting
NYU Langone
Verified postcode
New York, United States· Recruiting
McGill University
Verified postcode
Montreal, Canada· Recruiting
St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting
Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting
Copenhagen University Hospital
Verified postcode
Hvidovre, Denmark· Recruiting
Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting

Common questions

What is Nexpowder™?

Nexpowder™ is a special powder designed to be sprayed onto bleeding areas inside your digestive system to help stop the bleeding quickly.

What is an endoscopy?

An endoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your food pipe, stomach, and the first part of your small bowel.

Why is this study important?

This study helps doctors learn if Nexpowder™ is as good as current standard treatments for serious internal bleeding, which could lead to better care for patients.

Will I know which treatment I receive?

Because this is a 'randomized' study, you will be assigned to either Nexpowder™ or standard treatment by chance, and sometimes neither you nor your doctor will know which one you received.

How long will I be in the study?

The study involves your initial treatment and then follow-up checks, which will be explained in detail but typically span a period of weeks to months to monitor your recovery.

How to find out more

Geraldine Kelly

geraldine.kelly@medtronic.com +353014393000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.