Cryoablation System Shows 83.9% Recurrence-Free Rate in Kidney Cancer Trial
The ProSense Cryoablation System achieved an 83.9% recurrence-free rate in kidney cancer patients after 4 years in the ICESECRET trial. The system treats small renal masses up to 5 cm and is approved in multiple global markets. Detailed results will be presented at the European Conference on Interventional Oncology in April 2026.
The ProSense Cryoablation System demonstrated an 83.9% recurrence-free rate among 112 evaluable patients with kidney cancer in the ICESECRET clinical trial after a median follow-up of 4 years. Top-line findings from the prospective, multicenter, single-arm trial showed the system achieved mid-term local control for patients with small renal masses of 5 cm or smaller.
The ICESECRET trial enrolled 114 patients with 138 small renal mass lesions and used CT-guided ProSense ablation with standardized follow-up at 6 weeks, 6 months, 1 year, then annually through year 5. Recurrence-free status was achieved in 83.9% of evaluable patients at median 4 years, supporting the system's effectiveness in a single-arm, prospective multicenter setting.
The trial sought to create an ice ball that surrounds the whole tumor with 5 mm margins using the ProSense Cryoablation System, as observed under laparoscopic, ultrasound or CT imaging during the procedure. Safety was determined by monitoring procedure-related adverse events throughout the study.
More detailed data from the study will be presented at the European Conference on Interventional Oncology, which will take place from April 26 to 30, 2026, in Basel, Switzerland. The ProSense system is currently approved in the US, Europe and other key markets for the treatment of malignant and benign kidney tumors.
Small renal masses are increasingly detected due to increased imaging and represent a growing clinical challenge, particularly among elderly patients and those with comorbidities who are not suitable candidates for surgery. Minimally invasive, nephron-sparing treatment options that preserve kidney function, while effectively controlling tumors, are critically needed.
The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. Biologically low-risk breast cancer is defined as unifocal tumor, size 1.5 cm and smaller, ER-positive, PR-positive, HER2-negative, Ki-67 less than 15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma, and clinically negative lymph node.