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OpenTrials
Completed

NCT Number: NCT06086002

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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microwave ablation

Device

Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.

Primary outcomes

  1. Number of Participants with Technical Success

    Time frame: Immediately after ablation

    Technical success is defined as complete ablation of the index tumor with a safety margin equal to or greater than 5 mm, as confirmed on the computed tomography (CT) scan performed immediately after the ablation procedure.

  2. Number of Participants with Technique Efficacy at 1 Month

    Time frame: 1 month after ablation

    Technique efficacy is defined as the absence of residual or recurrent tumor at the ablation site (indicating complete ablation), as confirmed on the 1-month follow-up computed tomography (CT) scan.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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