Hepatocellular Carcinoma (HCC)SM-OCT-01NCT06682377
Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma
A study testing Radiofrequency ablation alone in people with Hepatocellular Carcinoma (HCC), run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Radiofrequency ablation alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Agreement to the protocol requirements and provision of informed consent.
- Age between 20 and 85 years.
- Child-Pugh Class A or B7.
- 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).
- 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.
- Histological diagnosis of HCC.
- No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.
Who cannot join
- Presence of three or more malignant liver tumors.
- Diffuse infiltrative type tumors with unclear boundaries.
- Recurrent HCC within two years of previous treatment.
- Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
- Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
- Vascular invasion by malignant liver tumors.
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- Severe coagulopathy (platelets <50,000/mm³ or International Normalized Ratio (INR) >50% prolongation).
- Presence of extrahepatic metastasis.
- Situations where obtaining appropriate data for the study is unlikely.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Efficacy of Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma: a Prospective Multicenter Study
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Radiofrequency ablation alone
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
No touch RFA with dual switching monopolar + bipolar mode
| Study group | Role | What they receive |
|---|---|---|
| No touch RFA with dual switching monopolar + bipolar mode | Experimental | Not described Receives: Procedure: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated local tumor progression rate
Measured: 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start5 Apr 2021
- Primary completion29 Mar 2024
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- 159 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
- NCT06682377
- Sponsor's protocol ID
- 2010-068-1163
- Acronym
- SM-OCT-01
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy of Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06682377
- Acronym / sponsor ID
- SM-OCT-01 / 2010-068-1163
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Nov 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No touch RFA with dual switching monopolar + bipolar mode | Experimental | Procedure: Radiofrequency ablation alone |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Agreement to the protocol requirements and provision of informed consent.
- Age between 20 and 85 years.
- Child-Pugh Class A or B7.
- 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.
- No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.
Key exclusion criteria (9 listed)
- Presence of three or more malignant liver tumors.
- Diffuse infiltrative type tumors with unclear boundaries.
- Recurrent HCC within two years of previous treatment.
- Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
- Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
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 |
|---|---|---|
| Radiofrequency ablation aloneNo touch RFA with dual switching monopolar + bipolar mode | Procedure or surgery | No touch RFA with dual switching monopolar + bipolar mode |
Primary outcome
Estimated local tumor progression rate
Time frame: 12 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone in people with Hepatocellular Carcinoma (HCC), 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 8 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: status not confirmed, as of the sponsor's last update on 12 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated local tumor progression rate (time frame: 12 months after procedure). 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 12 Nov 2024.