Robotic Magnetic Surgery: Results From the First Prospective Clinical Trial.

UNLABELLED

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 (21.6-50.4 kg/m). 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.