Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04124588 |
Other study ID # |
NEXTBIO-632-EWD3 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2018 |
Est. completion date |
November 11, 2021 |
Study information
Verified date |
February 2024 |
Source |
Next Biomedical Co., Ltd. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
A prospective, multi-center, randomized controlled trial to evaluate safety and effectiveness
of endoscopic hemostatic powder, 'Nexpowder' for hemostatic treatments of nonvariceal upper
gastrointestinal bleeding.
This study is a prospective, multi-center, single blind (for patients), controlled
investigation planned to evaluate safety and effectiveness of Nexpowder with 352 subject
patients.
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 treatment using Nexpower for patients with nonvariceal, upper gastrointestinal
bleeding from ulcers with high-risk stigmata (Forrest classification Ia, Ib, or IIa).
The primary end-points will be evaluated by assessing the rates of re-bleeding, which occur
over three (3) days following initial hemostasis achieved with the standard-of-care
hemostatic therapy.
Secondary end-points consist of evaluating three items: 1) Ease of use of Nexpowder applied
for the test group after reaching initial hemostasis, 2) Nexpowder device malfunction and 3)
safety follow-up to check occurrence of adverse event(s)/re-bleeding at 30-day (+5) time
point.
Only the subjects whose initial hemostasis has been achieved will be registered for this
investigation but those who initial hemostasis has failed to be reached with the
standard-of-care therapie(s) shall not be registered for this investigation.