Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhage | Device: HLBLS-200 | Not Applicable |
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:
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single Arm, Open Label, Single Center Exploratory Clinical Trial |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | June 19, 2019 |
Actual Primary Completion Date : | March 2, 2020 |
Actual Study Completion Date : | July 8, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: HLBLS-200
HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.
|
Device: HLBLS-200
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
|
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: (during screening period)
Inclusion Criteria: (during hepatectomy)
Exclusion Criteria: (during screening period)
Exclusion Criteria: (during hepatectomy)
Korea, Republic of | |
Hanyang Univ. Medical Center | |
Seoul, Korea, Republic of, 04763 |
Principal Investigator: | Dongho Choi, MD, Ph.D | Hanyang Univ. Medical Center |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | May 16, 2019 | ||||
First Posted Date ICMJE | May 21, 2019 | ||||
Last Update Posted Date | July 22, 2020 | ||||
Actual Study Start Date ICMJE | June 19, 2019 | ||||
Actual Primary Completion Date | March 2, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique | ||||
Official Title ICMJE | 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 | ||||
Brief 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:
|
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single Arm, Open Label, Single Center Exploratory Clinical Trial Masking: None (Open Label)Primary Purpose: Other |
||||
Condition ICMJE | Hemorrhage | ||||
Intervention ICMJE | Device: HLBLS-200
The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
|
||||
Study Arms ICMJE | Experimental: HLBLS-200
HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.
Intervention: Device: HLBLS-200
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
8 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 8, 2020 | ||||
Actual Primary Completion Date | March 2, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: (during screening period)
Inclusion Criteria: (during hepatectomy)
Exclusion Criteria: (during screening period)
Exclusion Criteria: (during hepatectomy)
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03957356 | ||||
Other Study ID Numbers ICMJE | LL-MD-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | HLB Cell Co., Ltd. | ||||
Study Sponsor ICMJE | HLB Cell Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | HLB Cell Co., Ltd. | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |