Liver Malignant TumorsNCT06426992
Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies
A study testing Starwave Microwave Ablation System, Microwave Ablation and Ultrasound-CT fusion guidance system in people with Liver Malignant Tumors, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Liver Malignant Tumors
- What is being tested?
- Starwave Microwave Ablation System, Microwave Ablation and Ultrasound-CT fusion guidance system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyun Hee Lee, 82-2-2072-4177, redlion55@naver.com
Jeong Min Lee, MD, PhD
About this study
Official title: 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.
Read the 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
- 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.
- Secondary Outcome Measures:
- 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.
- Ablation Volume: The volume of the necrosis area created by the MWA procedure.
- Procedure Time: Time from the insertion to the removal of the MWA antenna.
- Safety: Incidence and severity of procedure-related complications, graded using the Clavien-Dindo classification system.
- Conditions
- Liver Malignant Tumors
- Being tested
- Starwave Microwave Ablation System, Microwave Ablation, Ultrasound-CT fusion guidance system, Local anesthesia and Conscious sedation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starwave Microwave Ablation SystemDevice
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..
Microwave AblationProcedure or surgery
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").
Ultrasound-CT fusion guidance systemDevice
Fusion imaging of real-time ultrasound and pre-acquired CT/MRI will be used to guide the antenna placement and monitor the ablation process.
Local anesthesia and Conscious sedationDrug
Local anesthesia (e.g., 2% Lidocaine) and conscious sedation (e.g., Fentanyl and Midazolam) will be administered to the patient during the procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Starwave Microwave Ablation System; Procedure: Microwave Ablation; Device: Ultrasound-CT fusion guidance system; Drug: Local anesthesia and Conscious sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Measured: 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
Measured: 12 months after ablation
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start30 Apr 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426992
- Sponsor's protocol ID
- 2402-111-151
- Status last verified
- Sep 2025
- First submitted
- 19 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study
- ClinicalTrials.gov ID
- NCT06426992
- Acronym / sponsor ID
- 2402-111-151
- Conditions
- Liver Malignant Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- Secondary Outcome Measures:
- 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.
- Ablation Volume: The volume of the necrosis area created by the MWA procedure.
- Procedure Time: Time from the insertion to the removal of the MWA antenna.
- Safety: Incidence and severity of procedure-related complications, graded using the Clavien-Dindo classification system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patients with Malignant Liver Tumors | Experimental | Device: Starwave Microwave Ablation System, Procedure: Microwave Ablation, Device: Ultrasound-CT fusion guidance system, Drug: Local anesthesia and Conscious sedationFollowing 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starwave Microwave Ablation SystemA 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.. | Device | Experimental: Patients with Malignant Liver Tumors |
| Microwave AblationUnder 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"). | Procedure or surgery | Experimental: Patients with Malignant Liver Tumors |
| Ultrasound-CT fusion guidance systemFusion imaging of real-time ultrasound and pre-acquired CT/MRI will be used to guide the antenna placement and monitor the ablation process. | Device | Experimental: Patients with Malignant Liver Tumors |
| Local anesthesia and Conscious sedationLocal anesthesia (e.g., 2% Lidocaine) and conscious sedation (e.g., Fentanyl and Midazolam) will be administered to the patient during the procedure | Drug | Experimental: Patients with Malignant Liver Tumors |
Primary outcome
Technical success
Time frame: Immediately after ablation
Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Local tumor progression rate
Time frame: 12 months after ablation
Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success
2 secondary outcomes
Complication after ablation
Time frame: Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
Recurrence-free survival
Time frame: 12 months after ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starwave Microwave Ablation System, Microwave Ablation and Ultrasound-CT fusion guidance system in people with Liver Malignant Tumors, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun Hee Lee (82-2-2072-4177, redlion55@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Immediately after ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.