NCT03957356

Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique

Single Center, Single Arm, Open-label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique for Oozing Hemorrhage During Liver Resection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: HLB Cell Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. To investigate the safety of HLBLS-200 application. 2. To explore hemostatic function of HLBLS-200 in patients receiving hepatectomy.

Conditions

• Hemorrhage

Interventions

Type	Name	Description
DEVICE	HLBLS-200	The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.

Timeline

• Start date: 2019-06-19
• Primary completion: 2020-03-02
• Completion: 2020-07-08
• First posted: 2019-05-21
• Last updated: 2020-07-22

Locations

1 site across 1 country: South Korea