Tracking Renal Tumors After Cryoablation Evaluation (TRACE)

Primary Outcome Measures:

• Short and long term outcomes [ Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure ]
  The primary objective of the registry is to assess the short- and long-term outcomes of subjects who undergo renal lesion ablation via cryotherapy with products offered by Galil Medical.
  
  

Secondary Outcome Measures:

• Procedure method outcomes [ Time Frame: These outcomes are measured from the cryo procedure data. ]
  An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
  
  
• Standard of care follow-up procedures [ Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure ]
  Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.
  
  

The registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject. A subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care. Physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of TRACE. Subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician. The enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.