Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)

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.

NCT Number	NCT07629206
Lead Sponsor	IceCure Medical Ltd.
Conditions	Low-Risk, Early Stage Breast Cancer
Enrollment	400 participants
Start Date	2026-07-17
Primary Completion	2034-07 (estimated)
Study Completion	2034-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-06