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Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
Sponsor: IceCure Medical Ltd.
Summary
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy. This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment. In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.
Official title: Post Marketing Data Collection on Use of ProSense® Cryoablation System With Adjuvant Endocrine Therapy for the Treatment of Patients With Low-Risk, Early-Stage Breast Cancer (ChoICE Trial)
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-07
Completion Date
2034-09
Last Updated
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
Cryoablation
Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment. The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures.