IceCure Medical, developer of the minimally-invasive ProSense System for cryoablation, which destroys tumours by freezing, today announced interim results from the ICESECRET study for the treatment of patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery. Data were presented at the Urological Association Conference (14 December, Eilat, Israel). The presentation, titled “Renal Mass Cryoablation – Interim Analysis ICESECRET Study”, was delivered by Nasir Said (Bnai Zion Medical Center, Haifa, Israel).
According to the presentation, 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 12-60 months. In a subgroup of patients with no previous history of kidney cancer on the same kidney and a lesion ≤3cm, an 89.5% recurrence-free rate was observed 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. Five serious adverse events were reported, four of which were of mild severity and were treated conservatively and resolved within one to five days, with one severe complication of a new onset of ipsilateral hydronephrosis seven months after the cryoablation procedure that led to nephrectomy.
Cryoablation time and hospitalisation time were relatively short, up to approximately 25 minutes and two days, respectively. The presentation concluded that, based on these interim results, cryoablation is safe and effective for treating renal masses under five centimetres.
According to the American Journal of Roentgenology, small renal masses, which may be malignant or benign tumours in the kidney, have been rising in incidence over the past two decades. According to the American Cancer Society, in 2022, in the US, an estimated 79,000 new cases of kidney cancer will be diagnosed, with about 14,000 dying from the disease. Globally, there were more than 430,000 new cases of kidney cancer in 2020 and about 180,000 deaths according to World Cancer Research Fund International.
“These impressive interim results demonstrate the value of ProSense for urologists and interventional radiologists as a therapeutic alternative when patients are not eligible for surgery,” stated IceCure’s Chief Executive Officer, Eyal Shamir. “We believe the findings will support further use of ProSense in the jurisdictions in which our cryoablation system is approved for use with benign and malignant tissues of the kidney. The growing body of data on ProSense’s efficacy and safety across a broad range of indications supports commercialization momentum, particularly in facilities that benefit from one device that can be used across multiple specialties.”
ICESECRET, a prospective, multicentre, single-arm clinical trial is being performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center, Zerifin, Israel, and led by principal investigator Halahmi Sarel (Bnai Zion Medical Center, Haifa, Israel). The trial included 115 patients (138 lesions) with localized SRM of ≤5cm who were treated with ProSense cryoablation under computed tomography (CT) guidance. Full engulfment of the renal lesion, including a safety margin of 0.5cm was achieved in approximately 96% of the procedures where there was no anatomical limitation. Follow-up visits are performed 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.