Multicenter, single-blind, comparative, active controlled, non-inferiority, pivotal trial to assess safety and efficacy of absorbable, internal hemostat ‘InnoSEAL Plus DL’ compared with ‘TachoSil®’ in patients with persisting oozing after completing hemostasis with primary hemostasis method (ex. suture, ligation, vascular clip, argon beam coagulation, electrocauterization) during Intraperitoneal surgery (hepatectomy)

Multicenter, single-blind, comparative, active controlled, non-inferiority, pivotal trial to assess safety and efficacy of Absorbable, Internal emostat ‘InnoSEAL Plus DL’ compared with ‘TachoSil®’ in patients with persisting oozing after completing hemostasis with primary hemostasis method (ex. suture, ligation, vascular clip, Argon beam coagulation, electrocauterization) during Intraperitoneal surgery (Hepatectomy)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011267

Enrollment

Registered

2025-12-08

Start date

2022-06-22

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The randomized product will be cut 1–2 cm larger than the oozing-type bleeding area, applied after primary hemostasis during intra-abdominal surgery (hepatectomy), and compressed for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 19 years or older 2. Individuals diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, hepatolithiasis , metastatic liver cancer, or scheduled for liver resection due to liver transplantation 3. Patients experiencing persistent oozing-type bleeding* after primary hemostasis (e.g., suturing, ligation, vascular clips, argon beam coagulation, electrocautery, etc.) following liver resection *Oozing-type bleeding: Clinically silent capillary bleeding from tiny vessels, which does not require invasive intervention during the procedure. 4. Individuals who have voluntarily decided to participate in the clinical trial and provided written informed consent after receiving an explanation of the study 5. Individuals willing to comply with the clinical trial protocol

Exclusion criteria

Exclusion criteria: 1.Individuals with major bleeding* even after achieving hemostasis with primary methods. *Major bleeding: Spurting hemorrhage (arterial bleeding) or bleeding from major veins (hepatic veins joining the inferior vena cava). 2.Individuals with a history of cirrhosis and with portal hypertension. 3.Individuals with a history of liver transplantation or portal vein embolization. 4.Individuals with total bilirubin levels greater than 2.5 mg/dl. 5.Individuals confirmed to have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 120. 6.Individuals with severe coagulation disorders (international normalized ratio, INR > 2, or platelet count < 50 X 10^9/L). 7.Individuals receiving treatment with coagulation promoters (organ extract preparations, snake venom prepatations) or antithrombotic agents 8.Individuals with immune disorders. 9.Individuals with other conditions, including severe liver disease, disseminated intravascular coagulation (DIC), hemolytic and/or hemorrhagic anemia, or autoimmune diseases, as determined by the investigator to be unsuitable for this clinical trial. 10.Individuals with a history of severe surgical complications. 11.Individuals with a known hypersensitivity to the materials used in the investigational device (chitosan, gelatin, brilliant blue) or the comparator device (thrombin, fibrinogen, collagen, or horse-derived products such as anti-human lymphocyte globulin, anti-human thymocyte globulin, or dried horse venom antitoxin). 12.Individuals currently abusing drugs or alcohol. 13.Individuals requiring emergency liver resection surgery. 14.Pregnant or breastfeeding individuals. 15.Individuals who have participated in a clinical trial that may affect the outcome of this study within the last month. 16.Individuals deemed unsuitable for participation in this clinical trial by the investigator's judgment

Design outcomes

Primary

Measure	Time frame
3minute hemostasis success rate(%)	—

Secondary

Measure	Time frame
10minute hemostasis success rate(%);Hemostasis time (min);Rebleeding rate (%)	—

Countries

Korea, Republic of

Contacts

Public ContactGyu-Seong Choi

Samsung Medical Center

gyuseong.choi@samsung.com+82-2-3410-3477

Outcome results