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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.
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. This study has been designed to observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UI-EWD Hemostatic system | Experimental | Patients with upper gastrointestinal bleeding treated with UI-EWD |
|
| epinephrine | Active Comparator | Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UI-EWD Hemostatic system | Device | Adhesive endoscopic hemostats, powder type |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Woon Shin | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University College of Medicine | Bucheon-si | 14584 | South Korea | |||
| Inha University Hospital |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| epinephrine endoscopic injection (conventional therapy) |
| Drug |
endoscopic submucosal injection of epinephrine (1: 10,000) |
|
| Incheon |
| 22332 |
| South Korea |
| D013568 |
| Pathological Conditions, Signs and Symptoms |