RecruitingNot ApplicableNCT06539442

Versius Paediatrics Study

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


Sponsor

CMR Surgical Ltd

Enrollment

150 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Versius Surgical System for people with robotic surgical procedures in pediatric urology. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 0 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVersius Surgical System

Urological minimal access surgery performed with Versius Surgical System


Locations(3)

Department of Paediatric Urology, Evelina London Children's Hospital

London, United Kingdom

Department of Paediatric Urology Royal Manchester Children's Hospital

Manchester, United Kingdom

Department of Paediatric Urology Southampton Children's Hospital

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06539442