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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
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Soonchunhyang University College of Medicine
Bucheon-si, South Korea
Inha University Hospital
Incheon, South Korea
Start Date
May 23, 2016
Primary Completion Date
November 30, 2016
Completion Date
September 18, 2017
Last Updated
April 8, 2022
76
ACTUAL participants
UI-EWD Hemostatic system
DEVICE
epinephrine endoscopic injection (conventional therapy)
DRUG
Lead Sponsor
Next Biomedical Co., Ltd.
NCT07261228
NCT06297954
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06299007