Trial | NCT02978391  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    epinephrine ...

  • Study Participants

    76
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 Started
May 23
2016
Primary Completion
Nov 30
2016
Study Completion
Sep 18
2017
Last Update
Apr 08
2022

Device UI-EWD Hemostatic system

Adhesive endoscopic hemostats, powder type

Drug epinephrine endoscopic injection (conventional therapy)

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

UI-EWD Hemostatic system Experimental

Patients with upper gastrointestinal bleeding treated with UI-EWD

epinephrine Active Comparator

Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection

Criteria 

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
No Results Posted