The ICE3 Trial - Cryoablation of Small, Low-Risk Breast Cancer
ICE3 is the largest controlled multi-location clinical trial ever performed for liquid-nitrogen (LN2) –based cryoablation of small, low-risk, early-stage malignant breast tumors* without subsequently removing them. The trial began in 2014 and has completed recruitment of 206 patients in 19 hospitals and medical centers across the US, including Columbia University Medical Center and Mount Sinai Beth Israel.
*The FDA has not yet granted ProSense clearance for the treatment of breast cancer. Please refer to your country’s user manual for a list of approved indications in your region.
The ICE3 Trial - Cryoablation of Small, Low-Risk Breast Cancer
ICE3 is the largest controlled multi-location clinical trial ever performed for liquid-nitrogen (LN2) –based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. The trial began in 2014 and has completed recruitment of 206 patients in 19 hospitals and medical centers across the US, including Columbia University Medical Center and Mount Sinai Beth Israel.
*The FDA has not yet granted ProSense clearance for the treatment of breast cancer. Please refer to your country’s user manual for a list of approved indications in your region.
ICE3 Trial - Promising Interim Results
Based on an interim analysis performed in July 2022
96.91%
Recurrence Free
(188 out of the 194 eligible patients did not have a cancer recurrence as of July 2022)
100%
Safe Procedure
(No significant device-related adverse events or complications have been reported)
100%
Doctor & Patient Satisfaction with Cosmetic Results
(No scarring or change to the shape and size of the breast)
194
Eligible Patients
for Cryoablation
19
Hospitals
(Including Columbia University Medical Center and Mount Sinai Beth Israel)
82
Patients Followed
For 5 Years*
What Medical Experts Say About Cryoablation
“Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients, and at three years post-treatment, the ICE3 trial results are extremely positive. The non-invasive procedure is fast, painless and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring. Now, this trial is underscoring the efficacy and safety of the procedure for this patient group.”
Richard E. Fine, MD, FACS, Director of Education and Research and practicing breast surgeon at West Cancer Center’s Comprehensive Breast Center, TN and ICE3 Investigator
