Versius Paediatrics Study
- Conditions
- Robotic Surgical Procedures in Pediatric Urology
- Interventions
- Device: Versius Surgical System
- Registration Number
- NCT06539442
- Lead Sponsor
- CMR Surgical Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Versius Surgical System Versius Surgical System -
- Primary Outcome Measures
Name Time Method Adverse Event rate Up to 3 months post operation Incidence of adverse events
- Secondary Outcome Measures
Name Time Method Operative time Day of operation Surgery duration from skin incision to skin closure in minutes
Procedure completion Day of operation Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery
Unplanned readmission Up to 3 months post operation Unplanned hospital readmissions
MAG3 Renogram 3 months post stent removal MAG3 Renogram results
Post operative analgesic treatment Immediately after surgery Pain medication prescribed post-operatively
Length of stay Up to 3 months post operation, average 1 day Hospital stay from end of surgery to discharge in days
Device deficiencies and user errors Day of operation Device deficiencies and user errors that occur during surgery
Ultrasound grading 12 months post operation Ultrasound hydronephrosis grading results
Serious Adverse Event Rate Up to 3 months post-operation Incidence of serious adverse events
Blood loss Day of operation Estimated blood loss in mL
Reoperation 24 hours post operation Reoperation within 24 hours of surgery
Trial Locations
- Locations (3)
Department of Paediatric Urology Southampton Children's Hospital
🇬🇧Southampton, United Kingdom
Department of Paediatric Urology, Evelina London Children's Hospital
🇬🇧London, United Kingdom
Department of Paediatric Urology Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom