CMR Surgical embarks on world-first paediatric clinical trial using Versius
August 01 2024 - 1:00AM
UK Regulatory
CMR Surgical embarks on world-first paediatric clinical trial using
Versius
CMR Surgical embarks on world-first paediatric
clinical trial using Versius
- CMR Surgical has
commenced the world’s first multicentre prospective clinical trial
on the use of Versius in paediatric surgery
- Led by Mr
Ewan Brownlee, Consultant Paediatric Urologist at the Southampton
Children’s Hospital, part of the University Hospital Southampton
NHS Foundation Trust, the prospective clinical study will assess
the safety and efficacy of Versius, for use in urological
procedures in paediatric surgery
- The
clinical trial will take place over 3 clinical sites in the UK:
Southampton Children’s Hospital, Guy’s and St Thomas’ NHS
Foundation Trust, and Manchester University NHS Foundation
Trust
Cambridge, United Kingdom. 1 August
2024 07:00 (BST). CMR Surgical (CMR) – the global
surgical robotics business – has today announced that it has
commenced the first multicentre prospective clinical trial to
assess the safety and efficacy of Versius for use in paediatric
surgery. The trial is focusing on children and infants under the
age of 18, undergoing a range of urological procedures with Versius
including but not limited to robotic assisted pyeloplasty,
ureteroureterostomy, nephrectomy and Mitrofanoff formation.
The Versius Surgical Robotic System is a small, modular and
versatile surgical robot used for robotic assisted minimal access
surgery – a form of keyhole surgery. The uniquely small and modular
design of Versius allows the system to be set up in a way that
gives the surgeon optimal access in small, hard to reach spaces
within an operating zone, while maintaining clear access to the
patient for the anaesthetist and wider surgical team. The design of
Versius provides the opportunity to support surgeons to conduct
robotic-assisted paediatric surgery, and bring the benefits to more
patients.
The multicentre prospective clinical trial will be performed in
partnership with three clinical sites across the NHS. The
Department of Paediatric Urology at Southampton Children’s Hospital
– the primary site of the trial led by Mr Ewan Brownlee – has
become the first to perform paediatric urology surgery with Versius
in a clinical trial. The Department of Paediatric Urology at Royal
Manchester Children's Hospital part of Manchester University NHS
Foundation Trust, led by Mr David Keene; and 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.
Mark Slack, Co-founder and Chief Medical Officer at CMR
Surgical commented: “We are delighted to begin the
world’s first paediatric trials using Versius, in the UK. 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 paediatric 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 paediatrics.”
Ewan Brownlee, Chief Investigator of the prospective
clinical trial and Consultant Paediatric Surgeon at Southampton
Children’s Hospital commented: “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. 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 paediatric robotic surgery.”
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 and will
include a thorough clinical follow up of their surgical outcomes,
recovery and clinical outcomes for up to 1 year following the
surgery.
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, gynaecology, 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.
— ENDS —
Media Contacts:
If you wish to see more, please contact CMR Surgical at:
Press Office, CMR Surgical
T +44(0) 1223 755801
E pressoffice@cmrsurgical.com
Notes to editors:
The Versius Surgical Robotic System
Versius resets expectations of robotic surgery. Versius fits
into virtually any operating room set-up and integrates seamlessly
into existing workflows, increasing the likelihood of robotic
minimal access surgery (MAS). The small, portable and modular
design of Versius allows the surgeon to only use the number of arms
needed for a given procedure.
Biomimicking the human arm, Versius gives surgeons the choice of
optimised port placement alongside the dexterity and accuracy of
small fully-wristed instruments. With 3D HD vision, easy-to adopt
instrument control and a choice of ergonomic working positions, the
open surgeon console has the potential to reduce stress and fatigue
and allows for clear communication with the surgical team. By
thinking laparoscopically and operating robotically with Versius,
patients, surgeons and healthcare professionals can all benefit
from the value that robotic MAS brings.
But it’s more than just a robot. Versius captures meaningful
data with its wider digital ecosystem to support a surgeon’s
continuous learning. Through the Versius Connect app, Versius
Trainer and CMR clinical registry, Versius unleashes a wealth of
insights to ultimately improve surgical care.
About CMR Surgical Limited
CMR Surgical (CMR) is a global medical devices company dedicated
to transforming surgery with Versius, a next-generation surgical
robot.
Headquartered in Cambridge, United Kingdom, CMR is committed to
working with surgeons, surgical teams and hospital partners, to
provide an optimal tool to make robotic minimal access surgery
universally accessible and affordable. With Versius, we are on a
mission to redefine the surgical robotics market with practical,
innovative technology and data that can improve surgical care.
Founded in 2014, CMR Surgical is a private limited company
backed by an international shareholder base.
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