Tracking Renal Tumors After Cryoablation Evaluation - Full Text View

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	Device: Cryoablation


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Genetic and Rare Diseases Information Center resources: Kidney Cancer Renal Cancer

U.S. FDA Resources

Further study details as provided by Galil Medical:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.	Device: Cryoablation Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance Other Names: Visual-ICE cryoablation system SeedNet cryoablation system PresIce cryoablation system IceRod cryoablation needle IceRod PLUS cryoablation needle IceRod CX cryoablation needle IceEDGE 2.4 cryoablation needle IceSphere cryoablation needle

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

Study Population

Academic medical centers and community-based physicians

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117779

Contacts


Contact: Joy Benson, BA, CCRP	651-287-5112	joy.benson@galilmedical.com

Locations


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
United States, Colorado
Kaiser Permanente	Recruiting
Denver, Colorado, United States, 80205
Contact: Joy Benson joy.benson@galilmedical.com
Principal Investigator: Amit Sudan, MD
Sub-Investigator: Stephen Johnson, MD
Sub-Investigator: P. Anondo Stangl, MD
Sub-Investigator: Thomas Barsch, 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: 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
United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Contact: Joy Benson joy.benson@galilmedical.com
Sub-Investigator: David Sperling, MD
Sub-Investigator: Joshua Weintraub, MD
Sub-Investigator: Peter Schlossberg, MD
Sub-Investigator: Jonathan Susman, MD
Sub-Investigator: Vladimir Sheynzon, MD
Principal Investigator: Sven Wenske, MD
Sub-Investigator: Joel DeCastro, 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
Sub-Investigator: Asma Ahmad, MD

Sponsors and Collaborators

Galil Medical

Investigators


Study Chair:	Stephen Savage, MD	Medical University of South Carolina
Study Chair:	Peter Clark, MD	Vanderbilt University

More Information

Publications:

Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.

Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. Review.

Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11.

Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3.

Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70.

Finley DS, Beck S, Box G, Chu W, Deane L, Vajgrt DJ, McDougall EM, Clayman RV. Percutaneous and laparoscopic cryoablation of small renal masses. J Urol. 2008 Aug;180(2):492-8; discussion 498. doi: 10.1016/j.juro.2008.04.019. Epub 2008 Jun 11.


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:	July 11, 2014
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

ClinicalTrials.gov processed this record on March 03, 2015

Tracking Renal Tumors After Cryoablation Evaluation (TRACE)