Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized Controlled Trial to Evaluate Safety and Effectiveness of Endoscopic Hemostactic Powder, 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding

Conditions
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Nonvariceal Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Device: Nexpowder (Hemostatic powder)
* Device: Conventional Technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>After achieving initial hemostasis only with the standard-of-care, endoscopic hemostatic therapie(s) | Device: Nexpowder (Hemostatic powder)<br>* Nexpowder generates gelation-effects when the powder comes into contact with water, forms a physical barrier to control hemorrhage, preserve ulcer sites and thereby demonstrates its effective hemostatic performance. Hydrogels, which turned into gel-formation through water contacts in the gastrointestinal tract protect the wound sites for over 24 hours, are subsequently detached from the lesion, and completely excreted from the patient body system within 3 days.<br>Device: Conventional Technique<br>* Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).<br>|
| Active Comparator: Control gruop<br>After achieving initial hemostasis only with the standard-of-care, Wrap up the first endoscopy without adding an additional procedure. | Device: Conventional Technique<br>* Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of re-bleeding | Assessing the rates of re-bleeding, which occur over three (3) days following initial hemostasis achieved with the standard-of-care hemostatic therapy. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Adverse Events & Long term Re-bleeding | Safety follow-up to check occurrence of adverse event(s)/re-bleeding. | 30 days (+5) |