Versius Paediatrics Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorCMR Surgical Ltd

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

150 Participants
are divided into 1 treatment group

Sponsors and collaborators

CMR Surgical Ltd

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Collaborator