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

Next Biomedical Co., Ltd.76 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Upper Gastrointestinal Bleeding

Interventions

UI-EWD Hemostatic systemDEVICE

Adhesive endoscopic hemostats, powder type

epinephrine endoscopic injection (conventional therapy)DRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

Soonchunhyang University College of Medicine

Bucheon-si, South Korea

Inha University Hospital

Incheon, South Korea

Outcomes

Primary Outcomes

Recurrent bleeding rate

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.

Time frame: 3 days

Data from ClinicalTrials.gov

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