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Clinical Trials in South Korea / NCT06426992
Recruiting Not applicable

Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies

NCT06426992 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2024-04-30
Last updated
2026-04-13

Condition(s) studied

Liver Malignant Tumors

Investigational drug(s) / intervention(s)

Starwave Microwave Ablation SystemMicrowave AblationUltrasound-CT fusion guidance systemLocal anesthesia and Conscious sedation

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

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Child-Pugh Class A or B * Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered Exclusion Criteria: * In cases where there are three or more malignant liver tumors * When the maximum size of the tumor exceeds 4 cm * Diffuse infiltrative type of cancer with unclear tumor boundaries * When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more * Severe liver failure (Child-Pugh Class C) * In cases of vascular invasion by malignant liver tumors * Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%) * In cases of multiple extrahepatic metastases * Situations where it is highly unlikely to obtain appropriate data for research purposes

Primary outcome measure(s)

  • Technical success — Immediately after ablation
    Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
  • Local tumor progression rate — 12 months after ablation
    Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06426992 on ClinicalTrials.gov ↗ ← All trials in South Korea