Tracking Renal Tumors After Cryoablation Evaluation (TRACE)

Boston Scientific

Status: Terminated

Conditions: Kidney Neoplasms

Treatments: Device: Cryoablation

Study type: Observational

Funder types: Industry

Identifiers

NCT01117779

CUC10-RNL02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

246 participants in 1 patient group

Kidney lesions amenable to cryoablation

Description:

Kidney lesions treated with cryoablation.

Treatment:

Device: Cryoablation