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In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed.
Total number of target subjects 66 Test group 33 / Control group: 33 If endoscopic polypectomy is performed on polyps of 2cm or more, the probability of bleeding as a complication is 6.5%. This clinical study is an observational study to confirm the safety and effectiveness of Nexpowder, an endoscopic hemostatic powder after colonoscopy polypectomy, and an exploratory evaluation of 60 patients is conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Treatment | Active Comparator | Conventional Treatment |
|
| Conventional Treatment + Nexpowder | Experimental | Conventional Treatment + Nexpowder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexpowder | Device | Hemostatic powder for endoscopy after colonoscopy polypectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of rebleeding within 7 days of successful endoscopic hemostasis | Rate of rebleeding within 7 days of successful endoscopic hemostasis | 7 days |
| Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis) | Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group | Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group | 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period | Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kibae Kim, Ph.D. | Chungbuk National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea | ||||
| Chungnam National 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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| Conventional Treatment | Procedure | Standard hemostatic procedure |
|
| Perforation incidence |
Perforation incidence |
| 7 days |
| Death rate | Death rate | 7 days |
| Blood transfusion case rate | Blood transfusion case rate | 7 days |
| Number of Nexpowder applications (experimental group) | Number of Nexpowder applications (experimental group) | 7 days |
| Number of usage of Nexpowder (experimental group) | Number of usage of Nexpowder (experimental group) | 7 days |
| Incidence of device malfunction (experimental group) | Incidence of device malfunction (experimental group) | 7 days |
| Rate of ease of use (experimental group) | Rate of ease of use (experimental group) | 7 days |
| Daejeon |
| South Korea |
| Chungnam National University Sejong Hospital | Sejong | South Korea |
| D013568 |
| Pathological Conditions, Signs and Symptoms |