Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
A prospective, multi-center, multi-national, 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-national, multi-center, single blind (for patients),
 controlled investigation planned to evaluate safety and effectiveness of Nexpowder with 352
 subject patients.
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.
Inclusion Criteria:

 -  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 Criteria:

 -  Pregnant or breast-feeding patients