NCT02978391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2017

Completed
Last Updated

April 8, 2022

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

November 23, 2016

Last Update Submit

March 31, 2022

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days

Study Arms (2)

UI-EWD Hemostatic system

EXPERIMENTAL

Patients with upper gastrointestinal bleeding treated with UI-EWD

Device: UI-EWD Hemostatic system

epinephrine

ACTIVE COMPARATOR

Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection

Drug: epinephrine endoscopic injection (conventional therapy)

Interventions

UI-EWD Hemostatic systemDEVICE

Adhesive endoscopic hemostats, powder type

UI-EWD Hemostatic system
epinephrine endoscopic injection (conventional therapy)DRUG

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

epinephrine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soonchunhyang University College of Medicine

Bucheon-si, 14584, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong-Woon Shin

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 30, 2016

Study Start

May 23, 2016

Primary Completion

November 30, 2016

Study Completion

September 18, 2017

Last Updated

April 8, 2022

Record last verified: 2017-09

Locations

KR(2)