Tracking Renal Tumors After Cryoablation Evaluation (TRACE)

• ClinicalTrials.gov Identifier: NCT01117779
• Recruitment Status: Terminated
• First Posted: May 5, 2010
• Last Update Posted: December 19, 2020
• Sponsor: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
• Information provided by (Responsible Party): Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Kidney Neoplasms	Device: Cryoablation

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 250 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
• Actual Study Start Date: July 9, 2010
• Actual Primary Completion Date: November 24, 2020
• Actual Study Completion Date: November 24, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Short and long term outcomes [ Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure ]
   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 :

1. Procedure method outcomes [ Time Frame: These outcomes are measured from the cryo procedure data. ]
   An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.
2. Standard of care follow-up procedures [ Time Frame: These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure ]
   Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

University of California Irvine

Orange, California, United States, 92868

United States, Colorado

Kaiser Permanente

Denver, Colorado, United States, 80205

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, New York

Columbia University

New York, New York, United States, 10032

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

Investigators

• Study Chair: Stephen Savage, MD; Medical University of South Carolina
• Study Chair: Peter Clark, MD; Atrium Health

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, a wholly owned indirect subsidiary of Boston Scientific
• ClinicalTrials.gov Identifier: NCT01117779
• Other Study ID Numbers: CUC10-RNL02
• First Posted: May 5, 2010
• Last Update Posted: December 19, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Galil Medical, a wholly owned indirect subsidiary of Boston Scientific:

kidney tumors; renal tumors; renal cell carcinoma; kidney lesions; renal lesions; cryoablation; cryotherapy; cryosurgery

Additional relevant MeSH terms:

Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Kidney Diseases; Urologic Diseases