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NCT02978391 Clinical Trial

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

Upper Gastrointestinal Bleeding Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02978391
Other study ID # NEXTBIO-631-EWD3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2016
Est. completion date September 18, 2017

Study information
Verified date September 2017
Source Next Biomedical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date September 18, 2017
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• UI-EWD Hemostatic system
Adhesive endoscopic hemostats, powder type
Drug:
• epinephrine endoscopic injection (conventional therapy)
endoscopic submucosal injection of epinephrine (1: 10,000)

Locations
Country Name City State
Korea, Republic of Soonchunhyang University College of Medicine Bucheon
Korea, Republic of Inha University Hospital Incheon

Sponsors (1)
Lead Sponsor Collaborator
Next Biomedical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 days
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