NCT03957356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

June 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

May 16, 2019

Last Update Submit

July 20, 2020

Conditions

Hemorrhage

Keywords

HemostaticBlood oozingAbsorbent hemostaticLiver resectionIntraperitoneal surgery

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Hemostasis at the target blood oozing site

    within 10 minutes

  • Time to hemostasis

    within 10 minutes

  • Proportion of participants with abnormal laboratory value

    up to 12 weeks

  • Proportion of participants with operation site bleeding after hepatectomy

    up to 12 weeks

Study Arms (1)

HLBLS-200

EXPERIMENTAL

HLBLS-200, absorbent hemostactic powder, will be applied intraoperatively to stop blood oozing during hepatic resection.

Device: HLBLS-200

Interventions

HLBLS-200DEVICE

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

HLBLS-200

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject aged between 18 and 80 years old and scheduled for non-emergent hepatic resection.
  • Subject is willing to provide written consent and able to comply with study procedures.
  • Female subject of childbearing potential who is willing to use an adequate method of contraception or to be abstinent during the course of the study.
  • Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.

You may not qualify if:

  • Subject with a history of bleeding disorder, platelet disorder or bone marrow disorder.
  • Platelet count \< 50 X 10\^9/L or International normalized ratio \> 2.
  • Subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy.
  • Subject with a history of hypersensitivity to the substance of the investigational device.
  • Creatinine clearance \< 30mL/min
  • Aspartate transaminase or alanine aminotransferase ≥ 3.0 X upper limit of normal.
  • Subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation.
  • Subject with a history of alcohol or drug abuse.
  • Pregnant or lactating women
  • Subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study.
  • Subject who were judged by the investigator as inadequate for participation in the study.
  • Subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods
  • Subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy.
  • For other reason, subject who were judged by the investigator as inadequate for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang Univ. Medical Center

Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dongho Choi, MD, Ph.D

    Hanyang Univ. Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single Arm, Open Label, Single Center Exploratory Clinical Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 21, 2019

Study Start

June 19, 2019

Primary Completion

March 2, 2020

Study Completion

July 8, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

KR(1)