Study to Assess the Safety and Efficacy of Versius in Children
Research type
Research Study
Full title
Prospective Clinical Study to assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
IRAS ID
341869
Contact name
Ewan Brownlee
Contact email
Sponsor organisation
CMR Surgical Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 22 days
Research summary
This study is collecting evidence regarding the safety and efficacy of
Versius (robotic surgery medical device) in Urological Procedures in Paediatric patients. The study will consist of 3 main phases to ensure proper procedure development while monitoring patients’ safety. Feasibility and safety will be assessed on an ongoing basis. At the beginning there were be 3 surgeries performed at the hospitals and patients will be followed up for unexpected risks /adverse events. If
there are no safety concerns, 7 surgeries will be completed at the hospitals. Once the procedure is deemed safe according to safety data collected, the recruitment will proceed to recruit 140 additional patients from the 3 participating hospitals. The study patient population, is children and adolescents under the age of 18, which will be provided clinical care and follow-ups per standard of care and hospital's policy.REC name
West of Scotland REC 4
REC reference
24/WS/0046
Date of REC Opinion
3 Jun 2024
REC opinion
Further Information Favourable Opinion