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Microwave Ablation of Resectable Liver Tumors


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

Microwave Ablation of Resectable Liver Tumors


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

30 Days

Safety Issue:

No

Principal Investigator

Hisham El-Bayar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Joseph Hospital of Orange

Authority:

United States: Food and Drug Administration

Study ID:

09-008 Microwave Ablation

NCT ID:

NCT00892255

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver cancer
  • Tumors
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

The Center for Cancer Prevention & Treatment at St. Joseph HospitalOrange, California  92868