Clinical trial NCT06539442: Versius Paediatrics Study
Official title: Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Robotic Surgical Procedures in Pediatric Urology
Keywords: Pediatric
Paediatric
Versius
Urology
Robotic assisted surgery
minimal access surgery
minimally invasive surgery
Lead sponsor: CMR Surgical Ltd
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Southampton NHS Foundation Trust
First posted: 2024-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse Event rate
timeFrame: Up to 3 months post operation
Secondary outcomes:
measure: Procedure completion
timeFrame: Day of operation
measure: Serious Adverse Event Rate
timeFrame: Up to 3 months post-operation
measure: Ultrasound grading
timeFrame: 3 months post stent removal
measure: MAG3 Renogram
timeFrame: 3 months post stent removal
measure: Operative time
timeFrame: Day of operation
measure: Blood loss
timeFrame: Day of operation
measure: Post operative analgesic treatment
timeFrame: Immediately after surgery
measure: Length of stay
timeFrame: Up to 3 months post operation, average 1 day
measure: Reoperation
timeFrame: 24 hours post operation
measure: Unplanned readmission
timeFrame: Up to 3 months post operation
measure: Device deficiencies and user errors
timeFrame: Day of operation
measure: Ultrasound grading
timeFrame: 12 months post operation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Paediatric Urology, Evelina London Children's Hospital
city: Manchester
country: United Kingdom
facility: Department of Paediatric Urology Royal Manchester Children's Hospital
city: Southampton
country: United Kingdom
facility: Department of Paediatric Urology Southampton Children's Hospital
Study officials:
affiliation: Department of Paediatric Urology Southampton Children's Hospital
name: Ewan Brownlee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Paediatric Urology Royal Manchester Children's Hospital
name: David Keene, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Paediatric Urology, Evelina London Children's Hospital
name: Pankaj Mishra, MD
role: PRINCIPAL_INVESTIGATOR
References: