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Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child-Pugh Class A or B chronic hepatitis B or chronic hepatitis C or liver cirrhosis presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018 single lesion less than or equal to 3 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment Exclusion Criteria: number of recurrent HCCs, equal or more than 3 largest recurrent HCC size over 3 cm presence of vascular invasion by HCC diffuse infiltrative type HCC HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% presence of extrahepatic metastasis

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Overlapping ablation with single antenna

Simultaneous ablation with two antennas

Arm Description

Outcomes

Primary Outcome Measures

Technical success
Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 5 mm on immediate CT.
Technique efficacy
Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up CT.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06086002
Brief Title
Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma
Official Title
Evaluation of Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma: A Preliminary Prospective Single Center Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare safety and efficacy of microwave ablation with simultaneous ablation using two antennas versus overlapping ablation with single antenna for small hepatocellular carcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Overlapping ablation with single antenna
Arm Type
Active Comparator
Arm Title
Simultaneous ablation with two antennas
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Microwave ablation
Intervention Description
Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.
Primary Outcome Measure Information:
Title
Technical success
Description
Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 5 mm on immediate CT.
Time Frame
Immediately after ablation
Title
Technique efficacy
Description
Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up CT.
Time Frame
1 month after ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child-Pugh Class A or B chronic hepatitis B or chronic hepatitis C or liver cirrhosis presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018 single lesion less than or equal to 3 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment Exclusion Criteria: number of recurrent HCCs, equal or more than 3 largest recurrent HCC size over 3 cm presence of vascular invasion by HCC diffuse infiltrative type HCC HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% presence of extrahepatic metastasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Hee Lee
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyun Kim
Phone
82-2-2072-2519
Email
yyssaa21@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Hee Lee
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma

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