NCT06539442

Versius Paediatrics Study

Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: CMR Surgical Ltd · Industry
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Robotic Surgical Procedures in Pediatric Urology

Interventions

Type	Name	Description
DEVICE	Versius Surgical System	Urological minimal access surgery performed with Versius Surgical System

Timeline

• Start date: 2024-07-08
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-08-06
• Last updated: 2024-10-15

Locations

3 sites across 1 country: United Kingdom