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Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

18 Years
Open (Enrolling)
Kidney Neoplasms

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Trial Information

Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

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.


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).

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Short and long term outcomes

Outcome Description:

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.

Outcome Time Frame:

These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure

Safety Issue:


Principal Investigator

Jaime Landman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Irvine


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

January 2018

Related Keywords:

  • Kidney Neoplasms
  • kidney tumors
  • renal tumors
  • renal cell carcinoma
  • kidney lesions
  • renal lesions
  • cryoablation
  • cryotherapy
  • cryosurgery
  • Neoplasms
  • Kidney Neoplasms



Medical University of South Carolina Charleston, South Carolina  29425-0721
Columbia University New York, New York  10032-3784
Vanderbilt University Nashville, Tennessee  37232-6305
University of Kentucky Lexington, Kentucky  40536-0098
University of Nebraska Omaha, Nebraska  68198
Kaiser Permanente Denver, Colorado  80204-4507
University of California Irvine Irvine, California  92697