IceCure Medical, a developer of minimally-invasive cryoablation technology, has unveiled interim results from the clinical study of its ProSense cryoablation system.
ProSense is an advanced liquid-nitrogen-based cryoablation therapy for the treatment of both benign and cancerous tumours by freezing.
It deploys a minimally invasive technology that is safe and an effective alternative to hospital surgical tumour removal and can be easily performed in a relatively short procedure.
ICESECRET is a multicentre, single-arm clinical trial conducted at Bnai-Zion and Shamir Medical Centres, Israel, led by professor Halahmi Sarel as principal investigator.
The clinical trial evaluated ProSense System for treating patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery.
It recruited 115 patients with localised SRM of ≤5cm and were given treatment using the company’s ProSense cryoablation device under CT guidance.
According to the study data, 107 of the total participants have returned for follow-up with a mean duration of 22.8 months and a range of 12-60 months.
In the study, 107 patients showed an 85.1% recurrence-free rate at 16.5 months means a follow-up period.
A subgroup of patients with no previous history of kidney cancer showed an 89.5% recurrence-free rate at a mean follow-up time of 22.2 months.
IceCure chief executive officer Eyal Shamir said: “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.
“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 commercialisation momentum, particularly in facilities that benefit from one device that can be used across multiple specialities.”
The safety of the device has been evaluated by monitoring the procedure-related adverse events throughout the study period.
Five serious adverse events were reported, of which four were mild and were treated conservatively and resolved within five days.
One severe complication was related to the new onset of ipsilateral hydronephrosis seven months after the cryoablation procedure that led to nephrectomy.
The study data based on interim results concluded that cryoablation is safe and effective for treating renal masses under 5cm, said the cryoablation technology company.
