Microwave Ablation of Resectable Liver Tumors

NCT ID: NCT00892255

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-04-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Liver Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Microwave Ablation

Tumor tissue from the liver is inter-operatively treated with the microwave ablation device to measure the destruction of tissue.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph Hospital of Orange

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hisham El-Bayar, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Hospital of Orange

Locations

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The Center for Cancer Prevention & Treatment at St. Joseph Hospital

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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09-008 Microwave Ablation

Identifier Type: -

Identifier Source: org_study_id

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