IceCure Medical has received the Institutional Review Board (JHM-IRB) of West Cancer Center & Research Institute in Germantown, Tennessee, US, approval to begin patient enrolment for its post-marketing ChoICE Study.
The study will assess the use of ProSense, IceCure Medical’s cryoablation system, for treating early-stage, low-risk breast cancer in women aged 70 and older.
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ProSense is said to be the only device with marketing authorisation from the US Food and Drug Administration (FDA) for use alongside endocrine therapy in this particular patient group.
The study is designed to generate additional real-world evidence about ProSense’s use in treating biologically low-risk breast tumours equal to or smaller than 1.5cm in size, particularly in patients for whom surgery may not be an option.
Previous findings from IceCure Medical’s ICE3 trial indicated that ProSense cryoablation, followed by endocrine therapy, achieved a 3.1% local recurrence rate for early-stage, low-risk breast cancer.
According to survey responses from that study, 99.1% of patients and 97% of physicians reported satisfaction with the cosmetic outcome. These results contributed to the FDA’s marketing authorisation of ProSense for suitable patients aged 70 and above.
The study will involve 30 sites. Each centre will both participate in the study and offer ProSense cryoablation to appropriate patients who are not part of the trial.
This set-up is intended to expand access to the minimally invasive procedure beyond the clinical study setting.
In total, 400 patients are set to be enrolled. Margaret West Comprehensive Breast Center breast surgical oncologist Dr Richard Gilmore will lead the site.
Margaret West Comprehensive Breast Center is part of West Cancer Center & Research Institute.
IceCure Medical develops cryoablation systems using liquid nitrogen for destroying tumours, focusing on breast, bone, kidney and lung indications.
The company’s ProSense device is available in the US, Asia, and Europe for approved and cleared uses.
