Versius Paediatrics Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Versius Surgical System.
- Who it may be relevant to
- Registry conditions: Robotic Surgical Procedures in Pediatric Urology. Basic parameters: 0 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
Overview
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.
Interventions
- Device Versius Surgical System
Urological minimal access surgery performed with Versius Surgical System
Primary outcome measures
- Adverse Event rate [Time frame: Up to 3 months post operation]
Secondary outcome measures (12)
- Procedure completion [Time frame: Day of operation]
- Serious Adverse Event Rate [Time frame: Up to 3 months post-operation]
- Ultrasound grading [Time frame: 3 months post stent removal]
- MAG3 Renogram [Time frame: 3 months post stent removal]
- Operative time [Time frame: Day of operation]
- Blood loss [Time frame: Day of operation]
- Post operative analgesic treatment [Time frame: Immediately after surgery]
- Length of stay [Time frame: Up to 3 months post operation, average 1 day]
- Reoperation [Time frame: 24 hours post operation]
- Unplanned readmission [Time frame: Up to 3 months post operation]
- Device deficiencies and user errors [Time frame: Day of operation]
- Ultrasound grading [Time frame: 12 months post operation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 3 centers
- Department of Paediatric Urology, Evelina London Children's Hospital — London
- Department of Paediatric Urology Royal Manchester Children's Hospital — Manchester
- Department of Paediatric Urology Southampton Children's Hospital — Southampton
Identifiers
NCT: NCT06539442 · CA-00533