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Clinical Trials/NCT00892255
NCT00892255WithdrawnNot Applicable

Microwave Ablation of Resectable Liver Tumors

St. Joseph Hospital of Orange1 site in 1 countryStarted: April 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System

Time Frame: 30 Days

Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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