Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
18 Years
N/A
Both
Kidney Neoplasms
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.
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).
Type of Study:
Observational
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:
Yes
Principal Investigator
Jaime Landman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, Irvine
Authority:
United States: Institutional Review Board
Study ID:
CUC10-RNL02-01
NCT ID:
NCT01117779
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
Name | Location |
|---|---|
| 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 |
