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

NCT ID: NCT02978391

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-23

Study Completion Date

2017-09-18

Brief Summary

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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

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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.

Conditions

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Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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UI-EWD Hemostatic system

Patients with upper gastrointestinal bleeding treated with UI-EWD

Group Type EXPERIMENTAL

UI-EWD Hemostatic system

Intervention Type DEVICE

Adhesive endoscopic hemostats, powder type

epinephrine

Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection

Group Type ACTIVE_COMPARATOR

epinephrine endoscopic injection (conventional therapy)

Intervention Type DRUG

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

Interventions

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UI-EWD Hemostatic system

Adhesive endoscopic hemostats, powder type

Intervention Type DEVICE

epinephrine endoscopic injection (conventional therapy)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Next Biomedical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong-Woon Shin

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

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Soonchunhyang University College of Medicine

Bucheon-si, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NEXTBIO-631-EWD3

Identifier Type: -

Identifier Source: org_study_id

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