Versius Paediatrics Study
NCT Number: NCT06539442
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Robotic Surgical Procedures in Pediatric Urology
Interventions: DEVICE: Versius Surgical System
Sponsor: CMR Surgical Ltd
Collaborators: Solutions OP|University Hospital Southampton NHS Foundation Trust
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2027-01-01
Locations: Department of Paediatric Urology, Evelina London Children's Hospital, London, SE17EH, United Kingdom|Department of Paediatric Urology Royal Manchester Children's Hospital, Manchester, M139WL, United Kingdom|Department of Paediatric Urology Southampton Children's Hospital, Southampton, SO166YD, United Kingdom

Summary:
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.

Primary Outcome Measures: Adverse Event rate, Incidence of adverse events, Up to 3 months post operation
Secondary Outcome Measures: Procedure completion, Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery, Day of operation|Serious Adverse Event Rate, Incidence of serious adverse events, Up to 3 months post-operation|Ultrasound grading, Ultrasound hydronephrosis grading results, 3 months post stent removal|MAG3 Renogram, MAG3 Renogram results, 3 months post stent removal|Operative time, Surgery duration from skin incision to skin closure in minutes, Day of operation|Blood loss, Estimated blood loss in mL, Day of operation|Post operative analgesic treatment, Pain medication prescribed post-operatively, Immediately after surgery|Length of stay, Hospital stay from end of surgery to discharge in days, Up to 3 months post operation, average 1 day|Reoperation, Reoperation within 24 hours of surgery, 24 hours post operation|Unplanned readmission, Unplanned hospital readmissions, Up to 3 months post operation|Device deficiencies and user errors, Device deficiencies and user errors that occur during surgery, Day of operation|Ultrasound grading, Ultrasound hydronephrosis grading results, 12 months post operation