Diverticular Bleeding, Lower Gastrointestinal Bleeding
Conditions
Brief summary
Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract
Interventions
DEVICENexpowder™
Nexpowder™ hemostatic powder
Sponsors
Next Biomedical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 years or older at the time of screening * Patients diagnosed with diverticular bleeding
Exclusion criteria
* Patients diagnosed with upper gastrointestinal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding rate | 30 days post treatment | 30 days after successful endoscopic hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis rate | Immediately after the procedure | Hemostasis rate |
| Rebleeding rate | 7 days post treatment | Rebleeding rate |
Countries
South Korea
Outcome results
None listed