Status:
RECRUITING
Versius Paediatrics Study
Lead Sponsor:
CMR Surgical Ltd
Collaborating Sponsors:
University Hospital Southampton NHS Foundation Trust
Conditions:
Robotic Surgical Procedures in Pediatric Urology
Eligibility:
All Genders
Up to 17 years
Phase:
NA
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 (rob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06539442
Start Date
July 8 2024
End Date
January 1 2027
Last Update
October 15 2024
Active Locations (3)
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1
Department of Paediatric Urology, Evelina London Children's Hospital
London, United Kingdom, SE17EH
2
Department of Paediatric Urology Royal Manchester Children's Hospital
Manchester, United Kingdom, M139WL
3
Department of Paediatric Urology Southampton Children's Hospital
Southampton, United Kingdom, SO166YD