Versius Paediatrics Study

CMR Surgical

Status

Enrolling

Conditions

Robotic Surgical Procedures in Pediatric Urology

Treatments

Device: Versius Surgical System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06539442

CA-00533

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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