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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Malignant Tumors
• Intervention / Treatment: Device: Starwave Microwave Ablation System; Procedure: Microwave Ablation; Device: Ultrasound-CT fusion guidance system; Drug: Local anesthesia and Conscious sedation

Detailed Description

Study Design and-Purpose: This is a prospective, single-center clinical study to evaluate the effectiveness of microwave ablation (MWA) for treating small liver malignancies using the Starwave™ microwave generator and antenna. The primary purpose is to assess the 12-month local tumor recurrence rate. Secondary objectives include evaluating the technical success of achieving a ≥5 mm safety margin around the tumor, as well as procedural time, ablation volume, and safety.

Background: Hepatocellular carcinoma (HCC) and metastatic liver tumors are major causes of cancer-related death worldwide. For small tumors (≤5 cm), thermal ablation techniques like Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) are common treatment options, especially for patients who are not candidates for surgery. MWA offers several advantages over traditional RFA, including faster ablation times, larger ablation zones, and less susceptibility to the "heat sink" effect from nearby blood vessels. Achieving a sufficient safety margin (5-10 mm) around the tumor is critical to prevent local recurrence.

The Starwave™ MWA system, a domestic product in Korea, can deliver a higher maximum power output (150W) compared to some existing systems (e.g., Emprint™, 100W), potentially enabling more efficient energy delivery and larger, more spherical ablation zones. This study aims to prospectively evaluate the 12-month outcomes of this system, as no such data currently exists.

Eligibility Criteria The study will enroll 128 patients who meet the following key criteria. Inclusion Criteria: 1) Age 20-85 years; 2) Diagnosed with liver malignancy ≤4 cm in size (HCC, metastatic cancer, or recurrent/residual HCC); 3) Child-Pugh class A or B liver function; 4) Provided informed consent.

Exclusion Criteria:1) More than 3 malignant liver tumors; 2)Tumors larger than 4 cm; 3) Diffuse infiltrative type cancer;4) Severe coagulopathy or liver failure (Child-Pugh class C); 5) Tumor invasion into major hepatic vessels; 6) Intervention and Follow-up

Intervention: Patients will undergo percutaneous MWA using the Starwave™ system. The procedure will be performed under image guidance (ultrasound, often with CT/MR fusion imaging) with one or two 13-gauge antennas. The goal is to ablate the tumor and a 5-10 mm safety margin.

Follow-up: A CT or MRI scan will be performed immediately post-procedure to assess technical success. Subsequent follow-up with CT or MRI will occur approximately every 3 months for up to 12 months to monitor for local tumor recurrence.

Outcome Measures

1. Primary Outcome Measure: Local Tumor Recurrence Rate at 12 Months: The percentage of patients with tumor recurrence at the ablation site within 12 months, as assessed by CT or MRI.

2. Secondary Outcome Measures:

   1. Technical Success Rate: The percentage of procedures that achieve complete tumor ablation with a safety margin of at least 5 mm on the immediate post-procedure CT/MRI scan.
   2. Ablation Volume: The volume of the necrosis area created by the MWA procedure.
   3. Procedure Time: Time from the insertion to the removal of the MWA antenna.
   4. Safety: Incidence and severity of procedure-related complications, graded using the Clavien-Dindo classification system.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyun Hee Lee; Phone Number: 82-2-2072-4177; Email: redlion55@naver.com

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hyun Hee Lee; Phone Number: 82-2-2072-4177; Email: redlion55@naver.com
    • Principal Investigator: Jeong Min Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Patients with Malignant Liver Tumors; Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.

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..; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication after ablation	Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation.	Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
Recurrence-free survival	Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.	12 months after ablation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Anesthesia, Local; Conscious Sedation
• Other Study ID Numbers: 2402-111-151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No