Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT03957356
Eligibility Criteria:
Inclusion Criteria: (during screening period)
* 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.
Inclusion Criteria: (during hepatectomy)
* Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.
Exclusion Criteria: (during screening period)
* 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.
Exclusion Criteria: (during hepatectomy)
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03957356
Study Brief:
Protocol Section:
NCT03957356