This experiment is designed for post marketing data collection of a cryosurgical system \[PROSENSE™ of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).
A post marketing data collection of a cryosurgical system \[PROSENSE™\] of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
single arm, open label, PROSENSE™ treatment
Bnei Zion Medical Center
Haifa, Israel
Shamir Medical Center
Ẕerifin, Israel
Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
% of procedures with sufficient engulfment
Time frame: During intervention
Recurrence free survival
% of local recurrence events
Time frame: up to 5 years
Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.
Time frame: a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years
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