Nonthermal Plasma Ablation With PlasmaSure: A Novel Approach to Minimally Invasive Bladder Tumor Treatment

Purpose: Low-to-intermediate risk non–muscle-invasive bladder cancer is primarily characterized by recurrent, low-grade, noninvasive tumors. Although these tumors rarely metastasize, they frequently recur after treatment, necessitating repeated transurethral resections. CAPS Medical PlasmaSure is an innovative system that uses nonthermal atmospheric plasma in a minimally invasive procedure, designed to treat various types of tumors. This study evaluated the safety and efficacy of the PlasmaSure system for treating low-grade, stage Ta bladder cancer (BC). Materials and Methods: This was a prospective, multicenter, open-label, first-in-human trial. The study population comprised adult patients with a history of low-grade, stage Ta BC who had experienced recurrent papillary tumors. Eligible patients were treated with PlasmaSure for 3 to 6 minutes per tumor. Tumor and tissue responses were assessed using cystoscopy at 3 weeks and 3, 6, 9, and 12 months postprocedure. Results: In total, 30 patients were enrolled and treated with PlasmaSure. Overall, 67 tumors were treated across 36 procedures. The treatment was well-tolerated and safe, with no device-related adverse events, and a complete response was observed in 83% of patients and 84% of tumors. Patient-reported outcome questionnaire responses revealed minimal postprocedural pain and rapid recovery. Conclusions: PlasmaSure treatment demonstrated a high safety profile, tolerability, and efficacy. This finding paves the way for evaluating the utilization of PlasmaSure with a flexible cystoscope, which is expected to further benefit the patient by offering an anesthesia-free painless procedure.