Abstract
To evaluate a novel Magnetic Robotic Platform during reduced-port laparoscopic surgery in a prospective, multicenter clinical trial. BACKGROUND: Magnetic surgery has been developed to increase the benefits of minimally invasive surgery, with prior studies demonstrating its clinical benefits. Robotic-assisted surgery increases the surgeon's control over the instruments, offering less dependency on an assistant. The synergism of both techniques may escalate these individual benefits. METHODS: A prospective, multicenter, single-arm, open-label study was performed to assess the safety and performance of a robotic magnetic surgical system (Levita Robotic Platform). The investigational device was used during reduced-port laparoscopic cholecystectomy and laparoscopic bariatric surgery. The primary endpoints evaluated were safety and feasibility. Patients were followed for 30 days post-procedure. RESULTS: Between May 2021 and December 2021, 30 patients undergoing laparoscopic surgery were recruited. There were 22 females and 8 males with a mean age of 39 years (22-69 years) and median body mass index of 33 kg/m(2) (21.6-50.4 kg/m(2)). Procedures included 15 gastric sleeves, 14 cholecystectomies, and 1 Roux en-Y gastric bypass. The procedures were successfully performed by utilizing the robotic magnetic surgical system and a reduced-port technique in all 30 patients. No device-related serious adverse events were reported. The device provided adequate visualization and retraction in all cases. CONCLUSIONS: This clinical trial shows for the first time that this novel Magnetic Robotic Platform is safe and feasible in reduced-port laparoscopic cholecystectomy and laparoscopic bariatric surgery. This robotic platform brings the benefits of magnetic surgery in terms of reduction of incisions plus increasing the control for the surgeon.