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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorSeoul National University Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Starwave Microwave Ablation System
  • Microwave Ablation
  • Ultrasound-CT fusion guidance system
  • Local anesthesia and Conscious sedation

Treatment groups

128 Participants
are divided into 1 treatment group