Robotic Surgical Procedures in Pediatric Urology
Conditions
Keywords
Pediatric, Paediatric, Versius, Urology, Robotic assisted surgery, minimal access surgery, minimally invasive surgery
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.
Interventions
DEVICEVersius Surgical System
Urological minimal access surgery performed with Versius Surgical System
Sponsors
CMR Surgical Ltd
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event rate | Up to 3 months post operation | Incidence of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure completion | Day of operation | Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery |
| Serious Adverse Event Rate | Up to 3 months post-operation | Incidence of serious adverse events |
| Ultrasound grading | 3 months post stent removal | Ultrasound hydronephrosis grading results |
| MAG3 Renogram | 3 months post stent removal | MAG3 Renogram results |
| Operative time | Day of operation | Surgery duration from skin incision to skin closure in minutes |
| Blood loss | Day of operation | Estimated blood loss in mL |
| 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 |
| Reoperation | 24 hours post operation | Reoperation within 24 hours of surgery |
| Unplanned readmission | Up to 3 months post operation | Unplanned hospital readmissions |
| Device deficiencies and user errors | Day of operation | Device deficiencies and user errors that occur during surgery |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATOREwan Brownlee, MD
Department of Paediatric Urology Southampton Children's Hospital
PRINCIPAL_INVESTIGATORDavid Keene, MD
Department of Paediatric Urology Royal Manchester Children's Hospital
PRINCIPAL_INVESTIGATORPankaj Mishra, MD
Department of Paediatric Urology, Evelina London Children's Hospital
Outcome results
None listed