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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02978391

Enrollment

Registered

2016-11-30

Start date

2016-05-23

Completion date

2017-09-18

Last updated

2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Gastrointestinal Bleeding

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.

Interventions

DEVICEUI-EWD Hemostatic system

Adhesive endoscopic hemostats, powder type

DRUGepinephrine endoscopic injection (conventional therapy)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026