HCCNCT02675881
Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)
A study testing DSM and separable clustered electrode in people with HCC and Metastasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA). A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study. 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?
- DSM and separable clustered electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Aug 2013to 13 Jul 2015
- 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
- Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
- histologically confirmed HCC
- histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
- equal to or larger than 2cm, equal to or smaller than 5cm
- available cross-sectional liver imaging within 30 days before RFA
- signed informed consent
Who cannot join
- history of local treatment on the index tumor
- more than three tumors in a patient
- tumors in central portion of portal vein or hepatic vein
- Child-Pugh class C
- vascular invasion by tumors
- uncorrected coagulopathy
- presence of multiple extrahepatic metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.
Read the detailed description
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.
- Conditions
- HCC, Metastasis
- Being tested
- DSM, 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.
DSMDevice
Monopolar RFA using dual switching mode (DSM)
separable clustered electrodeDevice
Also called Octopus(R)
A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
| Study group | Role | What they receive |
|---|---|---|
| RFA DSM | Active comparator | Eligible patients who undergo RFA using DSM and separable clustered electrodes. Receives: Device: DSM; Device: separable clustered electrode |
| RFA SSM | No intervention | Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
local tumor progression (LTP)
Measured: 12 months
Secondary outcomes (3)
Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)
Measured: 1 months
rate of intrahepatic distant recurrence (IDR) after RFA
Measured: 12 months
rate of extrahepatic metastasis (EM) after RFA
Measured: 12 months
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 start5 Aug 2013
- Primary completion8 Apr 2015
- Study completion13 Jul 2015
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675881
- Sponsor's protocol ID
- SNUH-2013-1441
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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
- Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study
- ClinicalTrials.gov ID
- NCT02675881
- Acronym / sponsor ID
- SNUH-2013-1441
- Conditions
- HCC, Metastasis
- Keywords
- RFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Aug 2013 (actual)
- Primary completion
- 8 Apr 2015 (actual)
- Study completion
- 13 Jul 2015 (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.
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.
Detailed description
Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).
A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.
Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA DSM | Active comparator | Device: DSM, Device: separable clustered electrodeEligible patients who undergo RFA using DSM and separable clustered electrodes. |
| RFA SSM | No intervention | –Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
- histologically confirmed HCC
- histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
- equal to or larger than 2cm, equal to or smaller than 5cm
- available cross-sectional liver imaging within 30 days before RFA
Key exclusion criteria (7 listed)
- history of local treatment on the index tumor
- more than three tumors in a patient
- tumors in central portion of portal vein or hepatic vein
- Child-Pugh class C
- vascular invasion by tumors
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 |
|---|---|---|
| DSMMonopolar RFA using dual switching mode (DSM) | Device | RFA DSM |
| separable clustered electrodeAlso: Octopus(R)A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable. | Device | RFA DSM |
Primary outcome
local tumor progression (LTP)
Time frame: 12 months
3 secondary outcomes
Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)
Time frame: 1 months
rate of intrahepatic distant recurrence (IDR) after RFA
Time frame: 12 months
rate of extrahepatic metastasis (EM) after RFA
Time frame: 12 months
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: Yes
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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.
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 DSM 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 6 inclusion and 7 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?
local tumor progression (LTP) (time frame: 12 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.