Bipolar-Multipolar Radiofrequency Ablation of Small Renal Masses (<=4cm)
- Conditions
- kidney cancerrenal cell carcinoma10038430
- Registration Number
- NL-OMON35289
- Lead Sponsor
- Celon AG Medical instruments
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Pre-operative inclusion criteria
- Patient gives informed consent
- Patients with small renal mass [SRM] (<=4cm).
- The mass has to be a cortical tumor (not hilar)
Stop criterium
_ At the moment of procedure in case benign histology is found on frozen section biopsy, no RFA will be performed and the patient will not continue the study.
- Pregnancy
- SRM > 4cm
- SRM in hilar area
- Clotting disorder or anticoagulant use that cannot be interrupted
- Benign histology at intraoperative biopsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Find an energy dose that allows a complete destruction of the tumour. Tumor<br /><br>destruction will be studied by histopathology-immunohistochemistry. These data<br /><br>will be correlated to the energy used.</p><br>
- Secondary Outcome Measures
Name Time Method <p>none</p><br>