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Sponsor: CMR Surgical Ltd
Conditions: Robotic Surgical Procedures in Pediatric Urology
Interventions: Versius Surgical System
Countries: United Kingdom
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.
Sex: ALL
Age: 0 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Exclusion Criteria: * Patients ≥ 18 years old * Appropriate legal representative unwilling to provide written consent * Medical contraindication for general anaesthesia * Medical contraindication for laparoscopic procedure * Active pregnancy (in post-pubertal female patients) * Morbid obesity (BMI ≥ 40 kg/m2) * Patient participation in an interventional clinical study, that could impact primary objectives results * Prior pelvic /abdominal radiotherapy treatment * Subjects with other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure
- London, United Kingdom
- Manchester, United Kingdom
- Southampton, United Kingdom