Clinical trial · Interventional
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode
NCT03699657CI-TRIAL-00044162completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DSM | Device | — | UNRESOLVED |
| Separable clustered electrodes | Device | — | UNRESOLVED |
| SSM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- RFA with DSM mode
- description
- RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
- interventionNames
- Device: DSM
- Device: Separable clustered electrodes
- type
- ACTIVE_COMPARATOR
- label
- RFA with SSM mode
- description
- RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.
- interventionNames
- Device: SSM
- Device: Separable clustered electrodes
Primary outcomes (1)
- measure
- Minimum diameter of ablative zone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with HCC (\>= 1.5cm and \< 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA * no history of previous locoregional treatment Exclusion Criteria: * more than three HCC nodules * tumors abutting to the central portal vein or hepatic vein with a diameter \> 5 mm * Child-Pugh class C * tumors with major vascular invasion * extrahepatic metastasis * severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)
References
Publications (0)
Data not yet available
No reference posted for this study.