Medtronic has enrolled the first participant in the Expand URO US clinical trial of the Hugo robotic-assisted surgery (RAS) system.
Dr Michael Abern has performed the robotic-assisted prostatectomy procedure at Duke University Hospital in Durham, North Carolina.
The single-arm, prospective, multi-centre Expand URO trial will assess the performance and safety of the Hugo RAS system for urologic procedures.
The Hugo RAS system has been designed to reduce the ownership total cost and optimise system utilisation.
It is a modular and portable platform that can be moved between ORs and configure to fit both patient and procedure.
In the study, Hugo RAS system is intended to be utilised for urologic surgical procedures that include radical cystectomy, nephrectomy (partial or radical), and radical prostatectomy procedures at sites in the US.
The Expand URO clinical trial will enrol 122 patients at six sites in the country.
The company stated that the study is being conducted according to an Investigational Device Exemption received from the US Food and Drug Administration (FDA).
Medtronic Medical Surgical Portfolio Surgical Robotics business chief medical officer Carla Peron said: “Scientific evidence is the bedrock of healthcare technology innovation and adoption. It creates and builds trust among clinicians and patients.
“We’re proud to further that important pursuit with the Hugo RAS system in partnership with hospitals and surgical teams in the United States who share our commitment to patients.”
Combined with Touch Surgery Enterprise, the Hugo RAS system provides a smart, digitally enabled surgical experience.
Hugo is currently being used in various procedures in gynaecology, urology, and general surgery at hospitals across three continents, outside the US.
It received CE mark approval for use in urological and gynaecological procedures in October last year.