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Tracking Renal Tumors After Cryoablation Evaluation (TRACE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT01117779
First received: May 4, 2010
Last updated: August 10, 2016
Last verified: August 2016
  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:


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.


Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 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   (Adult, Senior)
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

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
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
Investigators
Study Chair: Stephen Savage, MD Medical University of South Carolina
Study Chair: Peter Clark, 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: August 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Galil Medical:
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

ClinicalTrials.gov processed this record on September 26, 2016