Using robotic surgery for pediatric urology procedures
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
NA · CMR Surgical Ltd · NCT06539442
This study is testing if robotic surgery is safe and effective for treating urological issues in children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | CMR Surgical Ltd (industry) |
| Locations | 3 sites (London and 2 other locations) |
| Trial ID | NCT06539442 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of the Versius robotic surgical system in performing urological procedures on children. It follows a multi-phase, single-arm design, where the first three procedures will be conducted at a single site to assess feasibility and safety. If deemed safe, additional cases will be performed to gather more data. The study is structured according to the IDEAL framework to ensure thorough evaluation and patient safety throughout the process.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old who require minimally invasive urological surgery and have parental consent.
Not a fit: Patients over 18 years old or those with medical contraindications for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and reduce recovery times for pediatric patients undergoing urological procedures.
How similar studies have performed: Other studies have shown promise in using robotic systems for surgical procedures, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London and 2 other locations
- Department of Paediatric Urology, Evelina London Children's Hospital — London, United Kingdom (NOT_YET_RECRUITING)
- Department of Paediatric Urology Royal Manchester Children's Hospital — Manchester, United Kingdom (NOT_YET_RECRUITING)
- Department of Paediatric Urology Southampton Children's Hospital — Southampton, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Ewan Brownlee, MD — Department of Paediatric Urology Southampton Children's Hospital
- Study coordinator: Mark Slack, MD
- Email: mark.slack@cmrsurgical.com
- Phone: +44 7766 024389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Robotic Surgical Procedures in Pediatric Urology, Pediatric, Paediatric, Versius, Urology, Robotic assisted surgery, minimal access surgery, minimally invasive surgery