UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD

UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.

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Key information

Conditions

Upper Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soonchunhyang University College of Medicine, Bucheon-si, South Korea

About this study

UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR

Exclusion criteria

Coagulation disorder (PLT < 50*10^9/L, INR > 2)
Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin during endoscopic treatment and after 72h endoscopy

Treatment and study plan

UI-EWD Hemostatic system

Device

Adhesive endoscopic hemostats, powder type

epinephrine endoscopic injection (conventional therapy)

Drug

endoscopic submucosal injection of epinephrine (1: 10,000)

Primary outcomes

Recurrent bleeding rate

Time frame: 3 days

Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin > 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope.

Sponsors and collaborators

Lead sponsor

Next Biomedical Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Nov 30, 2016
Registry last updated: Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed