Tracking Renal Tumors After Cryoablation Evaluation

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.

Suggested Inclusion Criteria:

- Patient is at least 18 years of age.

- Patient has a renal lesion suspicious for malignancy.

- Patient is to undergo renal lesion cryoablation via a Galil Medical cryoablation
system using Galil Medical needles for treatment of primary or recurrent disease.

- Patient is to be available for long-term follow-up per the enrolling physician's
standard care practices.

- Patient has provided written informed consent.

Suggested Exclusion Criteria:

- Patient is either currently using or has used within the last 30 days an
investigational product of any type.

- Patient has metastatic disease to or from the kidney.

- Patient has had previous therapy on the index lesion (e.g. radiofrequency,
cryoablation, partial nephrectomy).