HCCNCT02675894
Radiofrequency Ablation Using Cooled-Wet Electrode
A study testing cooled-wet electrode and separable clustered electrode in people with HCC and Metastasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- HCC, Metastasis
- What is being tested?
- cooled-wet electrode and separable clustered electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2014to 24 Apr 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
- liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
- signed informed consent
- treatment naive index tumor (no history of local treatment for an index tumor)
Who cannot join
- more than three tumors in a patients
- tumor size larger than 5cm
- tumor attaches to central portal vein or hepatic vein
- Child-Pugh classification C
- uncorrected coagulopathy
- presence of extrahepatic metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.
Read the detailed description
To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.
- Conditions
- HCC, Metastasis
- Being tested
- cooled-wet electrode, separable clustered electrode
- Keywords
- RFA
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooled-wet electrodeDevice
RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.
separable clustered electrodeDevice
Also called Octopus(R)
RFA is performed using separable clustered electrode in switching monopolar mode.
| Study group | Role | What they receive |
|---|---|---|
| RFA with cooled-wet electrode | Active comparator | RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance. Receives: Device: cooled-wet electrode |
| RFA with separable clustered electrode | Active comparator | RFA using separable clustered electrode in switching monopolar mode under the fused US guidance Receives: Device: separable clustered electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
LTP
cumulating local tumor progression rate over 2- year after RFA
Measured: 24 months
Secondary outcomes (7)
Technical success rate
technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)
Measured: 1 months
IDR rate
cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA
Measured: 24 months
EM rate
cumulating extrahepatic metastasis (EM) rate over 2- year after RFA
Measured: 24 months
Maximal diameter of ablative zone
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
Measured: 7 day
ablation time
RFA procedure time in each patient.
Measured: 1 day
Complication
all complication rate and grades (according to Clavien system from I to III) related with RFA procedure
Measured: 12 months
Volume of ablative zone
Volume of ablative zone on post-RFA CT or MRI in a mm3.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start14 Apr 2014
- Primary completion19 Jan 2017
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RF medical, Medical Research Collaborating Center
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675894
- Sponsor's protocol ID
- SNUH-2013-2283
- Status last verified
- Mar 2021
- First submitted
- 1 Feb 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
- ClinicalTrials.gov ID
- NCT02675894
- Acronym / sponsor ID
- SNUH-2013-2283
- Conditions
- HCC, Metastasis
- Keywords
- RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- RF medical, Medical Research Collaborating Center
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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.
To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.
Detailed description
To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA with cooled-wet electrode | Active comparator | Device: cooled-wet electrodeRFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance. |
| RFA with separable clustered electrode | Active comparator | Device: separable clustered electrodeRFA using separable clustered electrode in switching monopolar mode under the fused US guidance |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
- liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
- signed informed consent
- treatment naive index tumor (no history of local treatment for an index tumor)
Key exclusion criteria (6 listed)
- more than three tumors in a patients
- tumor size larger than 5cm
- tumor attaches to central portal vein or hepatic vein
- Child-Pugh classification C
- uncorrected coagulopathy
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 |
|---|---|---|
| cooled-wet electrodeRFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy. | Device | RFA with cooled-wet electrode |
| separable clustered electrodeAlso: Octopus(R)RFA is performed using separable clustered electrode in switching monopolar mode. | Device | RFA with separable clustered electrode |
Primary outcome
LTP
Time frame: 24 months
cumulating local tumor progression rate over 2- year after RFA
7 secondary outcomes
Technical success rate
Time frame: 1 months
IDR rate
Time frame: 24 months
EM rate
Time frame: 24 months
Maximal diameter of ablative zone
Time frame: 7 day
ablation time
Time frame: 1 day
Complication
Time frame: 12 months
Volume of ablative zone
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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Liver Cancer, Intrahepatic Cholangiocarcinoma
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.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooled-wet electrode and separable clustered electrode in people with HCC and Metastasis, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 18 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LTP (time frame: 24 months). 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 18 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.