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Microwave Ablation of Resectable Liver Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by St. Joseph Hospital of Orange
Sponsor:
Information provided by (Responsible Party):
St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:
NCT00892255
First received: April 30, 2009
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention
Hepatocellular Carcinoma
Liver Cancer
Device: Microwave Ablation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Microwave Ablation of Resectable Liver Tumors

Resource links provided by NLM:


Further study details as provided by St. Joseph Hospital of Orange:

Primary Outcome Measures:
  • Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier: NCT00892255     History of Changes
Other Study ID Numbers: 09-008 Microwave Ablation
Study First Received: April 30, 2009
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014