Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Malignant Tumors | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local anesthesia and Conscious sedation | Drug | — | UNRESOLVED |
| Microwave Ablation | Procedure | — | UNRESOLVED |
| Starwave Microwave Ablation System | Device | — | UNRESOLVED |
| Ultrasound-CT fusion guidance system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Patients with Malignant Liver Tumors
- description
- 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.
- interventionNames
- Device: Starwave Microwave Ablation System
- Procedure: Microwave Ablation
- Device: Ultrasound-CT fusion guidance system
- Drug: Local anesthesia and Conscious sedation
Primary outcomes (2)
- measure
- Technical success
- timeFrame
- Immediately after ablation
- description
- Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
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