About this trial
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device) in Urological Procedures in Paediatric population. In alignment with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework, this study will consist of 3 main phases to ensure proper procedure development while ensuring patients safety. Feasibility and safety will be assessed on an ongoing basis, and specifically after completion of the first 3 procedures, at a single site (Southampton/Lead), each conducted one week apart to allow the identification of unanticipated risks/adverse events. Once deemed safe, based on the results of the 3 cases enrolled in Phase I, 7 further cases would be completed, at the same site. Once the procedure is deemed safe according to safety data collected, the recruitment will proceed to full trial patient accrual, 140 additional cases from the 3 participating study sites.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.
Eligibility criteria
Qualifiers
Patients, male or female, (<18 years old) for whom an appropriate legal representative provides written consent for participation
Patient and disease factors deemed suitable for minimal access urological procedure
Multidisciplinary team (MDT) decision to treat with surgery
Patients under the care of the paediatric urology team in one of the participating centres
Disqualifiers
Patients ≥ 18 years old
Appropriate legal representative unwilling to provide written consent
Medical contraindication for general anaesthesia
Medical contraindication for laparoscopic procedure
Trial design
Treatments tested in this trial
- Versius Surgical System
Treatment groups
Sponsors and collaborators
CMR Surgical Ltd
Lead sponsor
University Hospital Southampton NHS Foundation Trust
Collaborator