IceCure’s ProSense Cryoablation System Evaluated for Kidney Tumors in ICESECRET Interim Results

December 9, 2024—IceCure Medical Ltd. recently announced interim results from the company’s ICESECRET study of cryoablation with its ProSense system for patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery.

According to the company, ICESECRET is a prospective, multicenter, single-arm clinical trial conducted at Bnai Zion Medical Center in Haifa, Israel, and Shamir Medical Center in Zerifin, Israel. Professor Halahmi Sarel, MD, is principal investigator of the study.

The trial includes 114 patients (138 lesions) with localized SRM of ≤ 5 cm ablated with ProSense cryoablation under CT guidance. Follow-up visits are performed 6 weeks, 6 months, 1 year, and then annually up to 5 years after the procedure. Based on CT imaging, data related to local recurrence is collected during the follow-up visits. Safety was determined by monitoring procedure-related adverse events throughout the study, advised the company.

Keren Boguslavsky, MD, of Bnai Zion Medical Center, presented the latest interim analysis data from ICESECRET at the Israeli Urological Association conference held December 2-5, 2024, in Eilat, Israel. Dr. Boguslavsky reported results at a mean follow-up period of 36 months for 111 patients with 117 lesions.

As summarized and characterized by the company in the press release, key results included the following:

• In 91 patients (approximately 82%), no tumor recurrence was observed.
• After an additional cryoablation procedure for the same tumor in 13 patients, the success rate for the overall population was 83.8%, with a mean follow-up time of 39.6 months. 
• In patients without a history of kidney cancer with one tumor < 3 cm, the success rate was 88.7%.
• Freezing of the renal tumor, including safety margins of 0.5 cm, was achieved in 95.6% of the procedures—demonstrating high efficacy in cases without anatomic limitation for ice ball creation.
• Four procedure-related serious adverse events were reported, three of which were mild and treated conservatively.
• One severe complication was observed at 7 months after the cryoablation procedure.
• Renal function was preserved, on an average basis across the patient cohort, with no significant change in creatinine and hemoglobin levels compared to baseline.
• The procedure time, relative to the standard of care as supported by and documented in medical literature, was short at approximately 25 minutes.

IceCure Medical’s flagship ProSense system is approved for benign and malignant kidney tumors in the United States, Europe, and numerous other countries. ProSense system is marketed and sold worldwide for indications cleared and approved to date including in the United States, Europe, and China.