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How Far Can Freezing Go in Replacing Excision? US Launches 400-Patient Postmarket Study in Low-Risk Breast Cancer
After ProSense was authorized for certain older patients with low-risk breast cancer, the first US study center is now officially in place; this five-year follow-up will examine whether the tradeoff for avoiding surgical excision falls within an acceptable range.
For some older patients with breast cancer, freezing the tumor with a thin needle and avoiding surgical excision may reduce the treatment burden. However, without a complete surgical specimen, physicians cannot use conventional pathology to confirm whether the tumor has been completely eliminated. IceCure Medical is now launching a 400-patient postmarket study in the United States to determine whether this convenience can deliver reliable long-term tumor control.
The company announced that West Cancer Center & Research Institute in Tennessee will become the first US clinical site for the ChoICE study. The study, registered as NCT07629206, is expected to enroll 400 patients at up to 30 centers beginning in July 2026, with a follow-up period of approximately five years. The study is sponsored by IceCure.
Participants are limited to patients aged 70 or older with a single lesion of invasive ductal carcinoma. Tumors must be no larger than 1.5 centimeters and must be estrogen receptor- and progesterone receptor-positive and HER2-negative. After undergoing cryoablation with ProSense, patients will not have the tumor excised and will receive five years of adjuvant endocrine therapy. The findings therefore cannot be extended to younger patients or breast cancer populations with larger tumors or different biological characteristics.
ProSense uses liquid nitrogen to create a low-temperature zone that destroys the localized tumor. In October 2025, the US Food and Drug Administration (FDA) authorized the system through the De Novo pathway for local treatment in the low-risk population described above; the conditions of use also require patients to receive adjuvant endocrine therapy. This is a clearly defined marketing authorization and does not mean that cryoablation has been proven to replace breast tumor excision surgery across the board.
The central question for ChoICE is the proportion of patients experiencing ipsilateral breast tumor recurrence within five years after treatment. The study will also record locoregional recurrence, disease-free survival, overall survival, breast cancer-specific survival, serious adverse events, and whether subsequent ipsilateral breast tumor excision or mastectomy is still required. Quality of life and satisfaction with cosmetic appearance will also be assessed.
The FDA required this postmarket surveillance because gaps remained in the evidence available before authorization. The previous pivotal study used a single-arm design and could not directly compare cryoablation with surgical excision in terms of efficacy, adverse events, or cosmetic outcomes. The sample size, missing five-year follow-up data, and inability to confirm complete ablation using an excised specimen also increased uncertainty in estimates of recurrence rates. The effects on recurrence and survival beyond five years are likewise currently unknown.
Under IceCure’s plan, participating centers may also become commercial ProSense treatment sites, offering treatment to eligible patients who are not enrolled in the study. This gives the launch of the first site both clinical and commercial significance, but it is not yet an efficacy milestone. The crucial evidence will depend on whether years of follow-up can demonstrate that recurrence risk, safety, and the need for salvage surgery remain within acceptable ranges.