Tracking Renal Tumors After Cryoablation Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

Conditions
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Kidney Neoplasms

Intervention / Treatment
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* Device: Cryoablation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney lesions amenable to cryoablation<br>Kidney lesions treated with cryoablation. | Device: Cryoablation<br>* Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance<br>* Other names: IceSphere cryoablation needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short and long term outcomes | 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. | These outcomes are measured at each follow-up visit out to 5 years post-cryo procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney tumors, renal tumors, renal cell carcinoma, kidney lesions, renal lesions, cryoablation, cryotherapy, cryosurgery