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

NCT06426992 | Recruiting DMC

• 1 other identifier: 2402-111-151
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Complication after ablation

  Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation

• Recurrence-free survival

  12 months after ablation

Study Arms (1)

Experimental: Patients with Malignant Liver Tumors

EXPERIMENTAL

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; Procedure: Microwave Ablation; Device: Ultrasound-CT fusion guidance system; Drug: Local anesthesia and Conscious sedation

Interventions

Microwave Ablation PROCEDURE

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").

Experimental: Patients with Malignant Liver Tumors

Starwave Microwave Ablation System DEVICE

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..

Experimental: Patients with Malignant Liver Tumors

Ultrasound-CT fusion guidance system DEVICE

Fusion imaging of real-time ultrasound and pre-acquired CT/MRI will be used to guide the antenna placement and monitor the ablation process.

Experimental: Patients with Malignant Liver Tumors

Local anesthesia and Conscious sedation DRUG

Local anesthesia (e.g., 2% Lidocaine) and conscious sedation (e.g., Fentanyl and Midazolam) will be administered to the patient during the procedure

Experimental: Patients with Malignant Liver Tumors

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Anesthesia, Local; Conscious Sedation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Hyun Hee Lee

CONTACT

82-2-2072-4177; redlion55@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-09

Locations

KR (1)