Back to resultsUI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD
Primary Purpose
Upper Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
UI-EWD Hemostatic system
epinephrine endoscopic injection (conventional therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Upper Gastrointestinal Bleeding
Eligibility 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
Sites / Locations
- Soonchunhyang University College of Medicine
- Inha University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UI-EWD Hemostatic system
epinephrine
Arm Description
Patients with upper gastrointestinal bleeding treated with UI-EWD
Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02978391
First Posted
November 23, 2016
Last Updated
March 31, 2022
Sponsor
Next Biomedical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02978391
Brief Title
UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
September 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Biomedical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UI-EWD Hemostatic system
Arm Type
Experimental
Arm Description
Patients with upper gastrointestinal bleeding treated with UI-EWD
Arm Title
epinephrine
Arm Type
Active Comparator
Arm Description
Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection
Intervention Type
Device
Intervention Name(s)
UI-EWD Hemostatic system
Intervention Description
Adhesive endoscopic hemostats, powder type
Intervention Type
Drug
Intervention Name(s)
epinephrine endoscopic injection (conventional therapy)
Intervention Description
endoscopic submucosal injection of epinephrine (1: 10,000)
Primary Outcome Measure Information:
Title
Recurrent bleeding rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Woon Shin
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University College of Medicine
City
Bucheon
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD
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