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Microwave Ablation of Resectable Liver Tumors

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ClinicalTrials.gov Identifier: NCT00892255
Recruitment Status : Unknown
Verified September 2012 by St. Joseph Hospital of Orange.
Recruitment status was:  Recruiting
First Posted : May 4, 2009
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Liver Cancer Device: Microwave Ablation

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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Microwave Ablation of Resectable Liver Tumors
Study Start Date : April 2009
Estimated Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System [ Time Frame: 30 Days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for liver resection, either for primary or metastatic disease
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892255


Contacts
Contact: Gitana Davila 714-734-6220 ext 41477 Gitana.Davila@stjoe.org
Contact: Carmen Moronez

Locations
United States, California
The Center for Cancer Prevention & Treatment at St. Joseph Hospital Recruiting
Orange, California, United States, 92868
Contact: Maria Gonzalez    714-734-6220      
Contact: Jessica Silvester    714-734-6220      
Principal Investigator: Hisham El-Bayar, MD         
Sub-Investigator: Aaron Sassoon, MD, Ph.D.         
Sub-Investigator: Hardeep Singh, M.D.         
Sponsors and Collaborators
St. Joseph Hospital of Orange
Investigators
Principal Investigator: Hisham El-Bayar, MD St. Joseph Hospital of Orange
More Information

Responsible Party: St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier: NCT00892255     History of Changes
Other Study ID Numbers: 09-008 Microwave Ablation
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by St. Joseph Hospital of Orange:
Liver cancer
Tumors

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases