Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

Official Title

Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

Details

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.

Keywords

Kidney Neoplasms kidney tumors renal tumors renal cell carcinoma kidney lesions renal lesions cryoablation cryotherapy cryosurgery Kidney lesions amenable to cryoablation

Eligibility

For people ages 18 years and up

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).

Locations

  • University of California Irvine
    Orange California 92868 United States
  • Kaiser Permanente
    Denver Colorado 80205 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Galil Medical
ID
NCT01117779
Study Type
Observational
Last Updated