Working… Menu

Tracking Renal Tumors After Cryoablation Evaluation (TRACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117779
Recruitment Status : Terminated (Boston Scientific acquisition of BTG/Galil Medical - business decision made to stop follow-up early)
First Posted : May 5, 2010
Last Update Posted : December 19, 2020
Information provided by (Responsible Party):
Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

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.

Layout table for study information
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

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

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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117779

Layout table for location information
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
Layout table for investigator information
Study Chair: Stephen Savage, MD Medical University of South Carolina
Study Chair: Peter Clark, MD Atrium Health
Layout table for additonal information
Responsible Party: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific Identifier: NCT01117779    
Other Study ID Numbers: CUC10-RNL02
First Posted: May 5, 2010    Key Record Dates
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases