To assess the ability to deliver full thickness bladder wall cryoablation via a cystoscopic approach using a new closed loop 6Fr cryocatheter and thermal dose controlled protocol.
Evaluations were conducted using a chronic porcine model wherein 10 lesions/animal were created throughout the bladder (bladder wall, trigone region, ureteral orifice and distal ureter). A 6Fr cryocatheter was passed through the working channel of a flexible cystoscope. Single 1 and 1.5min freeze protocols in a saline environment were evaluated and resultant lesion size was determined. A laparoscopic approach was utilized to visualize the transmural extension of the ice propagation.
Studies demonstrated the generation of transmural lesions characterized by full thickness histological necrosis following freezing for 1.5min regardless of tissue thickness (range: 2mm to 12mm). All animals were found to have good overall health (maintained weight, appetite, mobility, energy levels) throughout the recovery period. No significant deviations were noted in CBC and serum chemistry bloodwork with the exception of elevated Creatine Kinase levels. Importantly, no fistulas or perforations were noted.
The cryocatheter was able to rapidly and effectively freeze the bladder wall via a cystoscopic approach. The results showed the ability to consistently ablate a ~1cm diameter and up to 1.2cm deep using a single 1.5min freeze protocol. Analysis of the ablation efficacy revealed ~80% destruction within the frozen mass. Although further testing and refinement are needed, these studies demonstrate the potential of this new approach to provide a next-generation strategy for the treatment of bladder cancer.
Journal of endourology. 2024 Jan 27 [Epub ahead of print]
John M Baust, Anthony Corcoran, Anthony Robilotto, A E Katz, Kimberly Santicci, Robert VanBuskirk, John G Baust, Kristi Snyder
CPSI Biotech, 2 Court St, Owego, New York, United States, 13827; ., New York University Langone, Hospital-Long Island, Mineola, New York, United States; ., CPSI Biotech, Owego, New York, United States; ., New York University Langone, Hospital-Long Island, Urology, Mineola, New York, United States; ., CPSI Biotech, Owego, New York, United States; ., Binghamton University, 14787, Biological Sciences, Binghamton, New York, United States; ., Binghamton University, 14787, Biological Sciences, Binghamton, New York, United States; ., CPSI Biotech, Owego, New York, United States; .