The Expand URO US trial will evaluate the safety and performance of the Hugo RAS system for urologic surgical procedures, including radical prostatectomy, radical cystectomy, and nephrectomy procedures
Medtronic’s Hugo robotic-assisted surgery system. (Credit: Medtronic)
Healthcare technology company Medtronic has recruited the first patient in the Expand URO US clinical trial of its Hugo robotic-assisted surgery (RAS) system.
The Expand URO US clinical trial is being conducted after receiving an Investigational Device Exemption from the US Food and Drug Administration (FDA).
The study is designed to recruit up to 122 patients at six sites in the US.
The first robotic-assisted prostatectomy procedure was performed by Dr Michael R Abern at Duke University Hospital in Durham, North Carolina.
Abern said: “This is an exciting moment. Robotic-assisted surgery provides many benefits within my speciality of urology, and I am proud to have performed the first US clinical trial case with the Medtronic Hugo RAS system.”
Medtronic said that minimally invasive surgery, including robotic-assisted surgery, reduces complications, and duration of hospital stays and enables a faster return to normal activities. Urologic procedures are mostly performed with the assistance of a surgical robot.
The Expand URO US trial will use the Hugo RAS system for urologic surgical procedures, including radical prostatectomy, radical cystectomy, and nephrectomy procedures.
US Expand URO study principal investigator James Porter said: “This is an exciting time for healthcare in the United States and around the world, as we have the opportunity to expand robotic-assisted surgery treatment options to more patients.
“Backed by a growing body of clinical evidence, robotic-assisted surgery is the preferred approach within urology given the anatomical access, precision, and ergonomic advantages it enables.”
Medtronic said that its Hugo RAS system is being used at hospitals across three continents in a range of procedures within urology, gynaecology, and general surgery.
When used together with Touch Surgery Enterprise, the system offers a smart, digitally enabled surgical experience.
The company said its Hugo RAS system is an investigational device, not for sale in the US. It is commercially available in certain geographies outside the US.
Medtronic 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.”