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CMR Surgical’s Versius in an operating theater with a surgical team.
CMR Surgical has started its first multi-center clinical trial to assess the safety and efficacy of its Versius system for use in pediatric surgery. The trial is focusing on children and infants that are undergoing a range of urological procedures with Versius. These include, but are not limited to, robotic-assisted pyeloplasty, ureteroureterostomy, nephrectomy, and Mitrofanoff formation.
The trial will be performed in partnership with three clinical sites across the NHS. The primary site of the trial is the Department of Pediatric Urology at Southampton Children’s Hospital. This hospital was the first to perform pediatric urology surgery with Versius in a clinical trial.
“It is a privilege to be part of such a fantastic team here in Southampton; there is a huge list of people who have helped get us to this point of being able to start the first clinical trial using Versius in children and I am truly grateful to them all,” Ewan Brownlee, chief investigator of the prospective clinical trial and consultant pediatric surgeon at Southampton Children’s Hospital, said. “It has also been a pleasure to be able to collaborate with excellent colleagues in Manchester and the Evelina and with CMR to be able to deliver this trial. We are excited for what feels like a landmark step forward in the development of pediatric robotic surgery.”
Versius is a small, modular, and versatile surgical robot used for robotic-assisted menial access surgery, a form of keyhole surgery. Versius’ small and modular design gives surgeons access in small, hard-to-reach spaces within an operating zone while maintaining clear access to the patient for the anesthetist and wider surgical team.
More details about the study
The Department of Paediatric Urology at Royal Manchester Children’s Hospital, part of Manchester University NHS Foundation Trust, led by David Keene; and the Department of Paediatric Urology, and the Evelina London Children’s Hospital, part of Guy’s and St Thomas’ NHS Foundation Trust, led by Mr Pankaj Mishra make up the remaining sites taking part in the clinical trial.
This study has been evaluated and approved by the West of Scotland Research Ethics Committee, the Medicines and Health Care Products Regulatory Agency (MHRA) and the Health Research Authorities (HRA). A total of 150 patients will participate in the trial which will include a thorough clinical follow-up of their surgical outcomes, recovery, and clinical outcomes for up to 1 year following the surgery.
“We are delighted to begin the world’s first pediatric trials using Versius, in the UK,” Mark Slack, co-founder and chief medical officer at CMR Surgical, said. “The small, modular design of Versius, and small instrument diameter provides an opportunity to be able to perform robotic-assisted surgery for the treatment of pediatric patients. We are committed to the responsible introduction of Versius across new specialties and we look forward to working with our partners as we undertake this clinical trial to ensure the safety and efficacy of Versius in pediatrics.”
Versius has now been used in over 23,000 surgical cases, with over 130 different surgical procedures undertaken across seven surgical specialties. The system is in routine use across urology, general surgery, gynecology, colorectal surgery, and thoracic surgery. Versius is also being used in an ongoing clinical trial assessing the suitability of the system for use in transoral robotic surgery (TORS) at Liverpool University Hospitals NHS Foundation Trust’s (LUHFT) Aintree University Hospital.