Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Robotic Surgical Procedures in Pediatric Urology
- Sponsor
- CMR Surgical Ltd
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Adverse Event rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse Event rate
Time Frame: Up to 3 months post operation
Incidence of adverse events
Secondary Outcomes
- Operative time(Day of operation)
- Procedure completion(Day of operation)
- Unplanned readmission(Up to 3 months post operation)
- MAG3 Renogram(3 months post stent removal)
- Post operative analgesic treatment(Immediately after surgery)
- Length of stay(Up to 3 months post operation, average 1 day)
- Device deficiencies and user errors(Day of operation)
- Ultrasound grading(12 months post operation)
- Serious Adverse Event Rate(Up to 3 months post-operation)
- Blood loss(Day of operation)
- Reoperation(24 hours post operation)