Microwave Ablation of Resectable Liver Tumors
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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 |
- 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) |
-
Device: Microwave Ablation
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 |
Patients scheduled for liver resection, either for primary or metastatic disease
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| Contact: Gitana Davila | 714-734-6220 ext 41477 | Gitana.Davila@stjoe.org |
| Contact: Carmen Moronez |
| 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. | |
| 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:
|
Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site |
Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on June 13, 2013