The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors
NCT04044326 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-09-14
Summary
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, the researchers will perform MWA for 20 inoperable patients with liver cancers adjacent to inferior vena cava (IVC). The researchers will appraisal the clinical feasibility and advantage of the system by this study.
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- PROCEDURE
-
The Solero Microwave Ablation
The Solero Microwave Ablation system (Angiodynamics Ltd, USA) with a single microwave applicator operating at a 2.45 GHz will be used to perform MWA
Sponsors & Collaborators
-
National Taiwan University Hospital
lead OTHER
Principal Investigators
-
Kai-Wen Huang, MDPHD · NTUH
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-01
- Primary Completion
- 2020-01-06
- Completion
- 2020-01-22
Countries
- Taiwan
Study Locations
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