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NCT00892255 Clinical Trial

Microwave Ablation of Resectable Liver Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:
Microwave Ablation of Resectable Liver Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00892255
Other study ID # 09-008 Microwave Ablation
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date April 2009
Est. completion date April 2009

Study information
Verified date March 2021
Source St. Joseph Hospital of Orange
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this protocol is to pathologically evaluate the destruction by microwave ablation of primary and metastatic liver tumors. The primary aim is to measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.

Description:

Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy.The goal is to reduce morbidity and mortality and increase the ability to treat patients in the outpatient setting. Image-guided ablation is becoming an attractive alternative because of its relative low cost, its ability to provide large regions of coagulative necrosis in a controlled fashion, and its relatively low toxicity. Although image-guided ablative techniques have been extensively investigated for the treatment of liver tumors, there has been limited experience with microwave ablation (MWA) in the liver. This study will evaluate the treatment effect of MWA in liver tumors. Patients undergoing planned surgical removal of liver tumors will have the tumors intra-operatively treated with MWA. The histological changes will be evaluated upon removal of the specimen.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of primary or metastatic liver cancer for which surgery is planned - All participants need to be fully able to give informed consent Exclusion Criteria: - Mental or legal incompetence - Impaired decision-making capacity - Pregnant women may not participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Microwave Ablation
Tumor tissue from the liver is inter-operatively treated with the microwave ablation device to measure the destruction of tissue.

Locations
Country Name City State
United States The Center for Cancer Prevention & Treatment at St. Joseph Hospital Orange California

Sponsors (1)
Lead Sponsor Collaborator
St. Joseph Hospital of Orange

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation 30 Days
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