NCT02675894

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

February 1, 2016

Last Update Submit

March 17, 2021

Conditions

HCCMetastasis

Keywords

RFA

Outcome Measures

Primary Outcomes (1)

  • LTP

    cumulating local tumor progression rate over 2- year after RFA

    24 months

Secondary Outcomes (7)

  • Technical success rate

    1 months

  • IDR rate

    24 months

  • EM rate

    24 months

  • Maximal diameter of ablative zone

    7 day

  • ablation time

    1 day

  • +2 more secondary outcomes

Other Outcomes (2)

  • US/CT or MR fusion success rate

    1 day

  • Immediate assess of technique success rate

    2 days

Study Arms (2)

RFA with cooled-wet electrode

ACTIVE COMPARATOR

RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.

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

Device: separable clustered electrode

Interventions

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.

RFA with cooled-wet electrode
separable clustered electrodeDEVICE

RFA is performed using separable clustered electrode in switching monopolar mode.

Also known as: Octopus(R)
RFA with separable clustered electrode

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 5, 2016

Study Start

April 14, 2014

Primary Completion

January 19, 2017

Study Completion

April 24, 2018

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)