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

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Device: UI-EWD Hemostatic system; Drug: epinephrine endoscopic injection (conventional therapy)

• Registration Number: NCT02978391
• Lead Sponsor: Next Biomedical Co., Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-05-23
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-29
• Primary Completion: 2016-11-30
• Study First Posted: 2016-11-30
• Status Verified: 2017-09
• Study Completion: 2017-09-18
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UI-EWD Hemostatic system	UI-EWD Hemostatic system	Patients with upper gastrointestinal bleeding treated with UI-EWD
epinephrine	epinephrine endoscopic injection (conventional therapy)	Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection

Primary Outcome Measures

Name	Time	Method
Recurrent bleeding rate	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.

Trial Locations

Locations (2)

Soonchunhyang University College of Medicine; 🇰🇷 Bucheon, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of