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

N

Nextbiomedical

Status

Completed

Conditions

Upper Gastrointestinal Bleeding

Treatments

Drug: epinephrine endoscopic injection (conventional therapy)
Device: UI-EWD Hemostatic system

Study type

Interventional

Funder types

Industry

Identifiers

NCT02978391
NEXTBIO-631-EWD3

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

UI-EWD Hemostatic system
Experimental group
Description:
Patients with upper gastrointestinal bleeding treated with UI-EWD
Treatment:
Device: UI-EWD Hemostatic system
epinephrine
Active Comparator group
Description:
Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection
Treatment:
Drug: epinephrine endoscopic injection (conventional therapy)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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