IceCure Medical has added Adventist Health as a U.S. clinical site for its post-marketing study of a cryoablation treatment for low-risk breast cancer, the company announced through PR Newswire. The study, called ChoICE, is testing a procedure that uses extreme cold to destroy cancer cells rather than surgically removing tissue.
Cryoablation works by inserting a probe into a tumor and freezing it, killing the cancerous cells in place. The technique has been used in other cancer types for years, and IceCure has been developing it specifically for breast cancer patients whose tumors are small and classified as low-risk. The appeal of the approach is that it is minimally invasive compared to a lumpectomy or mastectomy and can potentially be performed in an outpatient setting.
The ChoICE study is a post-marketing effort, meaning IceCure's device has already received regulatory clearance and the study is designed to gather additional real-world data on outcomes, safety, and patient experience. Adding Adventist Health to the roster of participating sites expands the geographic reach of the study and increases the pool of eligible patients who can enroll.
Adventist Health operates hospitals and medical centers across several U.S. states, giving the study access to a broad patient population. Expanding the number of clinical sites is a standard step in post-marketing studies, where researchers aim to collect data across diverse patient groups and care settings.
For patients diagnosed with low-risk breast cancer, the prospect of a non-surgical treatment option is significant. Surgery carries risks including infection, scarring, anesthesia complications, and recovery time. A freeze-based outpatient alternative, if shown to be equally effective at eliminating cancer, could change treatment decisions for a meaningful share of newly diagnosed patients.
IceCure has not announced a timeline for when final ChoICE study results will be published or submitted to regulators. The study continues to enroll participants at its U.S. clinical sites.
