IceCure Medical has enrolled its first two patients across two clinical centres in the US for the ChoICE study, assessing its ProSense cryoablation system in low-risk breast cancer treatment.
The prospective, post-marketing trial intends to recruit approximately 400 individuals across as many as 30 US trial centres to gather real-world evidence within the indication cleared by the US Food and Drug Administration (FDA).
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Facilities participating in the programme are set to operate as both clinical trial locations and commercial providers, allowing them to administer ProSense cryoablation to qualifying individuals outside the trial cohort.
Enrolment commenced with a patient at West Cancer Center & Research Institute in Germantown, Tennessee, overseen by Margaret West Comprehensive Breast Center director and ICE3 study lead author Dr Richard Fine, examining cryoablation for small, low-risk breast tumours.
The second subject entered the study at Adventist Health Glendale in California, under breast surgeon Dr Dennis Holmes.
Both medical centres qualified for patient recruitment in August 2026 after executing site contracts and securing institutional review board approval.
IceCure also recently added Legacy Health’s Legacy Medical Group – Surgical Oncology at Good Samaritan Medical Center in Portland, Oregon, to the trial network.
IceCure Medical CEO Eyal Shamir said: “Enrolling the first patients marks continued progress in the execution of our post-market strategy for ProSense.
“As we continue to expand the ChoICE Study’s clinical network, we aim to generate additional real-world evidence while supporting broader clinical adoption and access to minimally invasive cryoablation for eligible patients.”
IceCure produces minimally invasive cryoablation equipment designed to eradicate tumours via freezing rather than surgical excision.
ProSense holds FDA clearance as the sole medical device indicated for the local treatment of biologically low-risk breast tumours measuring 1.5cm or smaller in patients aged 70 and older receiving adjuvant endocrine therapy, encompassing individuals ineligible for surgery.
The system is marketed internationally across Asia, Europe and the US for its cleared indications.
In August, IceCure Medical signed an exclusive distribution agreement with Scovas Medical for its ProSense cryoablation systems in the Netherlands.
