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

NCT06426992 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Liver Malignant Tumors

Interventions

PROCEDURE

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").

DEVICE

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.

DRUG

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

DEVICE

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..

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-08-30
Completion
2026-08-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426992 on ClinicalTrials.gov