Status:
COMPLETED
Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
Lead Sponsor:
Next Biomedical Co., Ltd.
Conditions:
Nonvariceal Upper Gastrointestinal Bleeding
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
A prospective, multi-center, randomized controlled trial to evaluate safety and effectiveness of endoscopic hemostatic powder, 'Nexpowder' for hemostatic treatments of nonvariceal upper gastrointestin...
Detailed Description
This investigational study is designed to compare effectiveness of using the standard-of-care hemostatic therapy only, versus the standard-of-care hemostatic therapy plus an additional hemostatic trea...
Eligibility Criteria
Inclusion
- Adult male or female with age of older than 19 years.
- Patients showing non-variceal upper GI bleeding symptoms
- An endoscopic examination indicates that the patients's ulcer is categorized Class Ia, Ib, or IIa according to the Forrest Classifications.
Exclusion
- Pregnant or breast-feeding patients
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2021
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT04124588
Start Date
November 1 2018
End Date
November 11 2021
Last Update
February 28 2024
Active Locations (3)
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1
Soon Chun Hyang University Bucheon Hospital
Gyeonggi-do, South Korea, 14584
2
Gachon Gil Hospital
Incheon, South Korea, 21565
3
Inha University Hospital
Incheon, South Korea, 22332