Tracking Renal Tumors After Cryoablation Evaluation

Boston Scientific Corporation246 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

246

Conditions

Kidney Neoplasms

Interventions

CryoablationDEVICE

Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (7)

University of California Irvine

Orange, California, United States

Kaiser Permanente

Denver, Colorado, United States

University of Kentucky

Lexington, Kentucky, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Changes in Lesion Size

Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.

Time frame: Baseline and months 6, 12, 24, 36, 48 and 60

Renal Function Status

Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min

Time frame: Baseline and months 6, 12, 24, 36, 48 and 60

Hospital Stay

Length of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.

Time frame: Average duration of 2 days or longer

Post-cryoablation Lesion Recurrence With Enhancement

Lesions with imaging that showed contrast enhancement based on investigator assessment.

Time frame: Months 6, 12, 24, 36, 48 and 60

Disease-specific Survival Rates

Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer. Subjects who are alive will be censored at date of their last visit. Subjects who have died from causes other than kidney cancer will be censored at the time of death. Patients are followed up for duration of registry which is 5 years.

Time frame: Month 60

Overall Survival Rates

Death due to any cause

Time frame: Month 60

Quality of Life Assessment

QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm-based scoring (NBS). This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range): GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1; VT 29.4-68.7, 39.4; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9; PCS 9.9-76,66 MCS 3.2-77.9,74.7

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.