Evaluate the safety and efficacy of Stopad versus Tachosil in open hepatic resection

A prospective, multicenter, single-blind, randomized, active-controlled, non-inferiority pivotal study to evaluate the safety and efficacy of Stopad versus Tachosil in patients with oozing after primary control of bleeding by standard techniques (such as sutures, ligatures, clips, vascular stapler, electrocautery, local radiofrequency ablation) in open hepatic resection

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004404

Enrollment

104

Registered

2019-10-30

Start date

2019-10-15

Completion date

Unknown

Last updated

2019-11-05

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 : Evaluate the safety and efficacy of Stopad versus Tachosil in open hepatic resection.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults over 19 2. Those who need a hepatic treatment for hepatic cancer, hepatic carcinoma, hepatic gallbladder cancer, metastatic liver cancer, and benign liver tumor 3. If an arterial beat hemorrhage or major venous hemorrhage persists after an open surgery after haemostasis by the primary haemostasis method (such as sutures, adhesives, vascular clips, vascular staplers, electrocautery, local high frequency resection, etc.) 4. A person who voluntarily decides and agrees to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1. Those who need emergency liver resection 2. In case participation in this clinical trial is not appropriate at the discretion of the Investigator due to coagulation disorder 3. Allergic or overreactive to Chitosan, Crustaceans, Batroxobin, anti-human lymphocytes Ig, Anti-thymocyre globulin, Freeze-dried Agkistrodon anti venom. 4. Drug abuse or alcoholism 5. Pregnant, nursing, or women planning to conceive within the clinical trial period or who do not agree with the proper use of contraceptives 6. In case of serious surgical complications during surgery affecting this clinical trial assessment by the Invester's judgment 7. Those currently receiving immunosuppressive treatment 8. Someone with a history of liver transplants 9. Participated in clinical trials of medicines or medical devices within one month of screening. However, it is possible to register if the validity and safety evaluation of this clinical trial is not affected by the judgment of the invester. 10. Other cases where the invester determines that they are not suitable for this clinical trial or may increase the risk associated with participating in the clinical trial.

Design outcomes

Primary

Measure	Time frame
hemostatic effectiveness(%)	—

Secondary

Measure	Time frame
hemostatic effectiveness(%)	—

Countries

Korea, Republic of

Contacts

Public Contactyoung Seomun

BioBud

youngsm@nc-bit.com+82-31-628-0820

Outcome results