IceCure, developer of the minimally-invasive cryoablation ProSense System which has shown promise in the treatment of renal masses, has announced that it has been used in a single-site study conducted at the Sorbonne University Department of Interventional Radiology and Oncology, Tenon Hospital in Paris, France by lead investigator François H Cornelis, (Memorial Sloan Kettering Cancer Center, New York, USA) and a team of doctors.
The study, titled “Pain-Free Survival After Percutaneous Image-Guided Cryoablation of Extraperitoneal Endometriosis” was published in the Journal of Vascular and Interventional Radiology (JVIR). The independent study and published paper were not sponsored by IceCure. Cornelis presented the study data at the Society of Interventional Radiology 2023 Annual Scientific Meeting (4–9 March, Phoenix, USA).
Cryoprobes used in the study were of two types: IceCure’s ProSense cryoprobe and Varian’s V-probe. The purpose of the study was to retrospectively evaluate the pain-free survival of percutaneous image-guided cryoablation of symptomatic extraperitoneal endometriosis (EE). In total, 42 patients with 47 lesions were treated. Patients were made aware that cryoablation was offered as a minimally invasive alternative to surgery, and that a surgical procedure may be performed if cryoablation failed. According to the published study, the therapeutic options to avoid the progression of endometriosis and reduce symptoms have been limited thus far to hormonal agents and wide surgical excision. In recent decades, minimally invasive techniques such as cryoablation have been suggested as a promising option to treat abdominal wall endometriosis with satisfactory outcomes and low morbidity.
Based on the following study outcome data, the study concluded that percutaneous cryoablation is a safe and effective procedure that significantly reduces pain and obtains local control of EE. The median follow-up was 13.5 months after cryoablation. The study’s conclusions included:
- Efficacy rate of cryoablation to avoid secondary surgery was 92.8% per patient and 93.6% per nodule treated.
- Median pain-free survival rates were 93.75% at six months and 82.72% after 12 months, 24 months, and 36 months.
- Pain decreased from a median of 8/10 on the visual analogue scale to 0/10 at the last follow-up (p<0.0001).
- Four patients had an adverse event in the days following the procedure, while one patient had a severe adverse event.
“We are grateful to Cornelis and the team of doctors at Sorbonne University and Tenon Hospital, where the data was collected, for having used our ProSense system, in addition to those from another company, as part of this independent study. Tenon Hospital institution is highly regarded in the field of interventional radiology,” stated Eyal Shamir, IceCure’s chief executive officer. “The ProSense system has regulatory approval in several countries, including US Food and Drug Administration (FDA) clearance for use as a cryosurgical tool in gynaecology, and we are pleased that doctors now have more evidence of cryoablation’s efficacy in patients with extraperitoneal endometriosis.”