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Active, not recruitingNCT06682377SM-OCT-01Updated Nov 12, 2024

Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma

An interventional study of Radiofrequency ablation alone in Hepatocellular Carcinoma (HCC), sponsored by Seoul National University Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Apr 2021, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Not applicable
Ages
20 Years to 85 Years
Sex
All
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Study summary

The purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "No-touch" technique. This approach employs Octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of hepatocellular carcinoma.

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Conditions studied

  • Hepatocellular Carcinoma (HCC)
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In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 159 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

**Inclusion Criteria**

  1. Agreement to the protocol requirements and provision of informed consent.
  2. Age between 20 and 85 years.
  3. Child-Pugh Class A or B7.
  4. Patients with liver cirrhosis who are candidates for radiofrequency ablation (RFA) based on multi-detector computed tomography (MDCT) or multi-detector computed tomography (MRI) within 60 days, with a suspected hepatocellular carcinoma (HCC) lesion of 1-3 cm.

    • **HCC Diagnostic Criteria:** A. Presence of risk factors (e.g., hepatitis B virus (HBV) positive, hepatitis C virus (HCV) positive, liver cirrhosis).

    B. Findings consistent with HCC on at least one imaging modality (MDCT, dynamic MRI, or Primovist MRI) according to the Korean Liver Cancer Association (KLCA) criteria.

    C. Histological diagnosis of HCC.

  5. No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.

**Exclusion Criteria**

  1. Presence of three or more malignant liver tumors.
  2. Diffuse infiltrative type tumors with unclear boundaries.
  3. Recurrent HCC within two years of previous treatment.
  4. Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
  5. Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
  6. Vascular invasion by malignant liver tumors.
  7. Severe coagulopathy (platelets \<50,000/mm³ or International Normalized Ratio (INR) >50% prolongation).
  8. Presence of extrahepatic metastasis.
  9. Situations where obtaining appropriate data for the study is unlikely.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
159 participants (estimated)

Study arms

  • Experimental
    No touch RFA with dual switching monopolar + bipolar mode

    Procedure: Radiofrequency ablation alone

Interventions

  • ProcedureRadiofrequency ablation alone

    No touch RFA with dual switching monopolar + bipolar mode

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What researchers measure

Primary outcomes

  1. Estimated local tumor progression rate

    Time frame: 12 months after procedure

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, Seoul, South Korea
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06682377
Responsible party
Jeong Min Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Nov 12, 2024
Start date
Apr 5, 2021
Primary completion
Mar 29, 2024
Completion
Dec 30, 2025 (estimated)
Last update
Nov 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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