U.S., June 6 -- ClinicalTrials.gov registry received information related to the study (NCT07629206) titled 'Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense(R) Cryoablation (ChoICE Trial)' on May 12.
Brief Summary: The FDA has granted marketing authorization for the ProSense(R) 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.
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