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Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies
Sponsor: Seoul National University Hospital
Summary
The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.
Official title: Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study
Key Details
Gender
All
Age Range
20 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-04-30
Completion Date
2026-08-30
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Starwave Microwave Ablation System
A microwave ablation system consisting of the Starwave™ microwave generator and a 13-gauge Starwave™ antenna. The generator has a maximum power output of 150W and is manufactured by STARmed Co., Ltd..
Microwave Ablation
Under fusion ultrasound guidance, one or two 13-gauge antennas are used to apply up to 150W of microwave energy to the tumor. Overlapping ablation is performed as needed to create an echogenic safety margin of 5-10 mm around the tumor. To prevent bleeding, the antenna is removed while applying energy ("hot withdrawal").
Ultrasound-CT fusion guidance system
Fusion imaging of real-time ultrasound and pre-acquired CT/MRI will be used to guide the antenna placement and monitor the ablation process.
Local anesthesia and Conscious sedation
Local anesthesia (e.g., 2% Lidocaine) and conscious sedation (e.g., Fentanyl and Midazolam) will be administered to the patient during the procedure
Locations (1)
Seoul National University Hospital
Seoul, South Korea