NCT01117779

Tracking Renal Tumors After Cryoablation Evaluation

Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 246 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Neoplasms

Interventions

Type	Name	Description
DEVICE	Cryoablation	Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Timeline

• Start date: 2010-07-09
• Primary completion: 2020-11-24
• Completion: 2020-11-24
• First posted: 2010-05-05
• Last updated: 2024-01-19
• Results posted: 2024-01-19

Locations

7 sites across 1 country: United States