Tracking Renal Tumors After Cryoablation Evaluation
Conditions
Kidney Neoplasms
Conditions: official terms
Kidney Neoplasms
Conditions: Keywords
kidney tumors, renal tumors, renal cell carcinoma, kidney lesions, renal lesions, cryoablation, cryotherapy, cryosurgery
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Cryoablation
Type: Device
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
Kaiser Permanente
Denver, Colorado, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
University of Kentucky
Lexington, Kentucky, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
University of Nebraska
Omaha, Nebraska, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
Columbia University
New York, New York, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
Medical University of South Carolina
Charleston, South Carolina, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
Vanderbilt University
Nashville, Tennessee, United States
Status: Recruiting
Contact: Joy Benson - joy.benson@galilmedical.com
Start Date
May 2010
Completion Date
January 2018
Sponsors
Galil Medical
Source
Galil Medical
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page