Tracking Renal Tumors After Cryoablation Evaluation (TRACE)
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment |
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Kidney Neoplasms | Device: Cryoablation |
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.
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Device: Cryoablation
Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
Other Names:
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- 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.
- 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.
- 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.

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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 |
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).

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 ClinicalTrials.gov identifier (NCT number): NCT01117779
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 |
Study Chair: | Stephen Savage, MD | Medical University of South Carolina | |
Study Chair: | Peter Clark, MD | Atrium Health |
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 Key Record Dates |
Last Update Posted: | December 19, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
kidney tumors renal tumors renal cell carcinoma kidney lesions |
renal lesions cryoablation cryotherapy cryosurgery |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Kidney Diseases Urologic Diseases |