Versius Paediatrics Study

Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics

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.

Study Overview

• Status: Recruiting
• Conditions: Robotic Surgical Procedures in Pediatric Urology
• Intervention / Treatment: Device: Versius Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morad Nakhleh, PhD; Phone Number: +44 7518 295217; Email: morad.nakhleh@cmrsurgical.com
• Study Contact Backup: Name: Mark Slack, MD; Phone Number: +44 7766 024389; Email: mark.slack@cmrsurgical.com

Study Locations

• United Kingdom
  • London, United Kingdom, SE17EH
    • Not yet recruiting
    • Department of Paediatric Urology, Evelina London Children's Hospital
    • Contact: Pankaj Mishra, MD
  • Manchester, United Kingdom, M139WL
    • Not yet recruiting
    • Department of Paediatric Urology Royal Manchester Children's Hospital
    • Contact: David Keene, MD
  • Southampton, United Kingdom, SO166YD
    • Recruiting
    • Department of Paediatric Urology Southampton Children's Hospital
    • Contact: Ewan Brownlee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Versius Surgical System	Device: Versius Surgical System; Urological minimal access surgery performed with Versius Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event rate	Incidence of adverse events	Up to 3 months post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure completion	Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery	Day of operation
Serious Adverse Event Rate	Incidence of serious adverse events	Up to 3 months post-operation
Ultrasound grading	Ultrasound hydronephrosis grading results	3 months post stent removal
MAG3 Renogram	MAG3 Renogram results	3 months post stent removal
Operative time	Surgery duration from skin incision to skin closure in minutes	Day of operation
Blood loss	Estimated blood loss in mL	Day of operation
Post operative analgesic treatment	Pain medication prescribed post-operatively	Immediately after surgery
Length of stay	Hospital stay from end of surgery to discharge in days	Up to 3 months post operation, average 1 day
Reoperation	Reoperation within 24 hours of surgery	24 hours post operation
Unplanned readmission	Unplanned hospital readmissions	Up to 3 months post operation
Device deficiencies and user errors	Device deficiencies and user errors that occur during surgery	Day of operation
Ultrasound grading	Ultrasound hydronephrosis grading results	12 months post operation

Collaborators and Investigators

• Sponsor: CMR Surgical Ltd
• Collaborators: University Hospital Southampton NHS Foundation Trust
• Investigators: Principal Investigator: Ewan Brownlee, MD, Department of Paediatric Urology Southampton Children's Hospital; Principal Investigator: David Keene, MD, Department of Paediatric Urology Royal Manchester Children's Hospital; Principal Investigator: Pankaj Mishra, MD, Department of Paediatric Urology, Evelina London Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; minimally invasive surgery; Urology; Paediatric; minimal access surgery; Robotic assisted surgery; Versius
• Other Study ID Numbers: CA-00533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No