MedTrace Logo

Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding

NCT02717416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2022-01-26

No results posted yet for this study

Summary

Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. Despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years.

EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized study.

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DEVICE

Endo-Clot

After epinephine injection therapy, Endo-Clot is applied immediately onto the bleeding lesion. A total of 2 g of AMP® particle powder will be sprayed onto the bleeding lesion by a catheter inserted through a working channel of the endoscope under continuous air flow.

DEVICE

hemoclip or electrical coagulation

After epinephrine injection therapy, hemoclip (HX-610-135, Olympus, Japan) will be applied onto the bleeding lesions. The number of hemoclip will be decided by endoscopist. Electrical coagulation will be applied onto the bleeding lesions.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2021-04-26
Completion
2021-05-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717416 on ClinicalTrials.gov