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| Name | Class |
|---|---|
| Next Biomedical Co., Ltd. | INDUSTRY |
| Tan Tock Seng Hospital | OTHER |
| National University Hospital, Singapore | OTHER |
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The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowderâ„¢ for hemostasis in pilot cohort of patients with NVUGIB in Singapore
24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowderâ„¢ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic hemostasis using Nexpowder | Experimental | Subjects with non variceal upper GI bleeding will undergo nndoscopic hemostasis using Nexpowder as primary treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexpowder | Device | Endoscopic hemostasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| endoscopic hemostasis | endoscopic hemostasis success rate | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent bleeding rate on second-look endoscopy | recurrent bleeding rate on second-look endoscopy | 24 hours |
| hydrogel persistence rate at the bleeding site | hydrogel persistence rate at the bleeding site |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | 529889 | Singapore |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D006396 | Hematemesis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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prospective single arm intervention cohort
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| 24 hours |
| Recurrent bleeding within 30 days after endoscopic therapy | Recurrent bleeding within 30 days after endoscopic therapy | 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |