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CMR Surgical’s Versius with the surgical team in the operating room.
CMR Surgical has initiated the first multi-center clinical trial to evaluate the safety and efficacy of the Versius system for use in pediatric surgery. The trial will involve children and infants undergoing a variety of urologic procedures with Versius, including but not limited to robotic-assisted pyeloplasty, ureteroureterotomy, nephrectomy, and Mitrofanoff formation.
The trial is being conducted in collaboration with three clinical facilities across the NHS. The primary facility for the trial is the Paediatric Urology Unit at Southampton Children’s Hospital, which was the first hospital to perform paediatric urology surgery with Versius in the clinical trial.
“It’s an honour to be joining such a fantastic team in Southampton. There are so many people who have helped us get our first clinical trial in children using Versius and I’d like to thank them all,” said Ewan Brownlee, lead investigator and consultant paediatric surgeon at Southampton Children’s Hospital. “It’s also been a pleasure to work with our fantastic colleagues in Manchester and Evelina, as well as CMR, to deliver this trial. I’m really excited about what I feel is a groundbreaking step forward in the development of paediatric robotic surgery.”
Versius is a small, modular, and versatile surgical robot used for robotic-assisted meningeal access surgery, a form of keyhole surgery. Versius’s compact, modular design allows surgeons to access small, hard-to-reach spaces within the surgical field, while still allowing the anesthesiologist and the wider surgical team clear access to the patient.
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More about the study
The other institutions taking part in the trial are the Department of Paediatric Urology at the Royal Manchester Children’s Hospital, part of Manchester University NHS Foundation Trust, led by David Keen, the Department of Paediatric Urology at Guy’s and St Thomas’ NHS Foundation Trust, led by Mr Pankaj Mishra, and Evelina London Children’s Hospital.
The study was assessed and approved by the West of Scotland Research Ethics Committee, the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Research Agency (HRA). A total of 150 patients will participate in the trial, which includes thorough clinical follow-up of surgical outcomes, recovery and clinical outcomes for up to one year after surgery.
“We are excited to launch the world’s first pediatric trial using Versius in the UK,” said Mark Slack, Co-Founder and Chief Medical Officer of CMR Surgical. “Versius’ compact, modular design and small instrument diameter provide the opportunity to perform robotic-assisted surgery to treat pediatric patients. We are committed to responsibly introducing Versius into new specialties and look forward to working with our partners as we conduct this 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 performed across seven surgical specialties. The system is routinely used in urology, general surgery, obstetrics and gynaecology, colorectal surgery and thoracic surgery. Versius is also being used in an ongoing clinical trial at Liverpool University Hospitals NHS Foundation Trust (LUHFT) Aintree University Hospital to assess its suitability for use in transoral robotic surgery (TORS).
