RecruitingNot ApplicableNCT06426992

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

Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study


Sponsor

Seoul National University Hospital

Enrollment

128 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the effectiveness and safety of microwave ablation (a procedure using focused heat) to destroy liver tumors — either primary liver cancer or cancer that has spread to the liver from elsewhere — using a specific device called the Starwave microwave generator. **You may be eligible if...** - You have a suspected or confirmed liver tumor (hepatocellular carcinoma or metastatic liver cancer) that is 4 cm or smaller - Your liver function is adequate (Child-Pugh Class A or B) - You have had a recent scan (CT, MRI, or ultrasound) confirming the tumor within the past 60 days **You may NOT be eligible if...** - You have 3 or more malignant liver tumors - Your tumor is larger than 4 cm - Your tumor has poorly defined borders (diffuse type) - Your tumor is very close (within 5 mm) to major blood vessels or bile ducts - You have severely impaired liver function (Child-Pugh Class C) - You have cancer that has invaded blood vessels - You have severe blood clotting problems - You have multiple tumors outside the liver as well Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStarwave 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..

PROCEDUREMicrowave 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").

DEVICEUltrasound-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.

DRUGLocal 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

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NCT06426992


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