Tracking Renal Tumors After Cryoablation Evaluation (TRACE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Kidney Neoplasms |
Procedure: Cryoablation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry |
- Short and long term outcomes [ Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure ] [ Designated as safety issue: Yes ]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.
- Procedure method outcomes [ Time Frame: These outcomes are measured from the cryo procedure data. ] [ Designated as safety issue: Yes ]An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
- Standard of care follow-up procedures [ Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure ] [ Designated as safety issue: No ]Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Kidney lesions amenable to cryoablation
Kidney lesions treated with cryoablation.
|
Procedure: Cryoablation
Cryoablation with Galil Medical cryoablation systems and needles under imaging guidance
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Academic medical centers and community-based physicians
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).
Contacts and Locations| Contact: Joy Benson, BA, CCRP | 651-287-5112 | joy.benson@galilmedical.com |
| United States, California | |
| University of California Irvine | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Jaime Landman, MD | |
| Sub-Investigator: Ralph Clayman, MD | |
| Sub-Investigator: Achim Lusch, MD | |
| United States, Colorado | |
| Kaiser Permanente | Recruiting |
| Denver, Colorado, United States, 80205 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Amit Sudan, MD | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Stephen Strup, MD | |
| Sub-Investigator: Jason Bylund, MD | |
| Sub-Investigator: Paul Crispen, MD | |
| Sub-Investigator: Ramakrishna Venkatesh, MD | |
| United States, Nebraska | |
| University of Nebraska | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Chad LaGrange, MD | |
| Sub-Investigator: Gregory Gordon, MD | |
| Sub-Investigator: Michael Feloney, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Ketan Badani, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Stephen Savage, MD | |
| Sub-Investigator: Harry Clarke, MD | |
| Sub-Investigator: Jonathan Picard, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Joy Benson joy.benson@galilmedical.com | |
| Principal Investigator: Stanley Duke Herrell, MD | |
| Sub-Investigator: Peter Clark, MD | |
| Sub-Investigator: Geoffrey Wile, MD | |
| Study Chair: | Jaime Landman, MD | University of California, Irvine |
| Study Chair: | Stanley Duke Herrell, MD | Vanderbilt University |
More Information
Publications:
| Responsible Party: | Galil Medical |
| ClinicalTrials.gov Identifier: | NCT01117779 History of Changes |
| Other Study ID Numbers: | CUC10-RNL02-01 |
| Study First Received: | May 4, 2010 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Galil Medical:
|
kidney tumors renal tumors renal cell carcinoma kidney lesions |
renal lesions cryoablation cryotherapy cryosurgery |
Additional relevant MeSH terms:
|
Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013