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This is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will recruit approximately 8 subjects.
Patients scheduled for hepatic resection who voluntarily agree to participate the study will be recruited for the screening procedures.
Patients who meet the eligibility criteria will be assigned to the study. Subjects will receive HLBLS-200 as a supplementary hemostatic technique for oozing hemorrhage which can be occurred during hepatic resection.
A dose of HLBLS-200 based on the area of liver resection will be applied and time to hemostasis of blood oozing will be evaluated.
Patients will be followed for 12 weeks after application of HLBLS-200 to monitor any adverse event.
Study objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLBLS-200 | Experimental | HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLBLS-200 | Device | The amount of HLBLS-200 applied will be determined by the investigator based on the resection area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis at the target blood oozing site | Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application | within 3 minutes |
| Adverse Event | Incidence of Adverse Event after application of HLBLS-200 | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis at the target blood oozing site | Proportion of participants achieving hemostasis within 5, 7, 10 minutes after HLBLS-200 application | within 10 minutes |
| Time to hemostasis | Time to hemostasis at the target blood oozing site after HLBLS-200 application |
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Inclusion Criteria: (during screening period)
Inclusion Criteria: (during hepatectomy)
Exclusion Criteria: (during screening period)
Exclusion Criteria: (during hepatectomy)
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| Name | Affiliation | Role |
|---|---|---|
| Dongho Choi, MD, Ph.D | Hanyang Univ. Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang Univ. Medical Center | Seoul | 04763 | South Korea |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single Arm, Open Label, Single Center Exploratory Clinical Trial
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| within 10 minutes |
| Proportion of participants with abnormal laboratory value | Safety evaluation | up to 12 weeks |
| Proportion of participants with operation site bleeding after hepatectomy | Hemorrhage at the operation site | up to 12 weeks |