Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
Start Date
7/17/2026
Completion Date
9/1/2034
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.
Eligibility Criteria
Age Range: 70 years to No maximum
Interventions
Cryoablation
Conditions
Locations
Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Glendale, California 91206
United States
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee 38138
United States