IceCure’s ProSense Cryoblation System Evaluated for Treating Small Renal Tumors

January 4, 2023—IceCure Medical Ltd., an Israel-based developer of the minimally invasive ProSense cryoablation system, recently announced interim results from the ICESECRET study of ProSense for the treatment of patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery.

ProSense is a liquid nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing. The system is marketed and sold worldwide for the indications cleared to-date by the FDA and approved in Europe with the CE Mark.

According to the company, ICESECRET is a prospective, multicenter, single-arm clinical trial enrolling patients at Bnai-Zion Medical Center in Haifa, Israel, and Shamir Medical Center in Zerifin, Israel. The study is led by Principal Investigator Professor Halahmi Sarel, MD.

The trial is composed of 115 patients (138 lesions) with localized SRM of ≤ 5 cm who were treated with ProSense cryoablation under CT guidance. Full engulfment of the renal lesion, including a safety margin of 0.5 cm was achieved in approximately 96% of the procedures where there was no anatomic limitation.

In the study, follow-up visits are performed at 6 weeks, 6 months, 1 year, and then annually up to 5 years after the procedure. During the follow-up visits, data related to local recurrence, based on CT imaging, is collected. Safety was determined by monitoring procedure-related adverse events throughout the study.

Nasir Said, MD, of Bnai Zion Medical Center presented the data in a presentation entitled “Renal Mass Cryoablation—Interim Analysis ICESECRET Study” at the Urological Association Conference in Eilat, Israel, on December 14, 2022.

As summarized in the company’s press release, Dr. Said reported that out of the 115 patients enrolled, 107 patients (112 lesions) returned for follow-up with a mean duration of 22.8 months and a range of 12 to 60 months.

The findings included the following:

• In a subgroup of patients with no previous history of kidney cancer on the same kidney and a lesion ≤ 3 cm, there was an 89.5% recurrence-free rate at a mean follow-up time of 22.2 months when the procedure protocol was followed.
• The recurrence-free rate was 85.1% for the 107 patients (91 patients, including 13 patients who underwent a second cryoablation), at a mean follow-up period of 16.5 months.
• There were five serious adverse events, four of which were of mild severity and were treated conservatively and resolved within 1 to 5 days. The one severe complication was a new onset of ipsilateral hydronephrosis at 7 months after the cryoablation procedure that led to nephrectomy.
• Cryoablation time and hospitalization time were relatively short, up to approximately 25 minutes and 2 days, respectively.

The presentation’s conclusion was that, based on these interim results, cryoablation is safe and effective for treating renal masses under 5 cm, stated the company.