Versius Paediatrics Study

NCT06539442 | Recruiting

• 1 other identifier: CA-00533
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Robotic Surgical Procedures in Pediatric Urology

Keywords

Pediatric; Paediatric; Versius; Urology; Robotic assisted surgery; minimal access surgery; minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• Adverse Event rate

  Incidence of adverse events

  Up to 3 months post operation

Secondary Outcomes (12)

• Procedure completion

  Day of operation

• Serious Adverse Event Rate

  Up to 3 months post-operation

• Ultrasound grading

  3 months post stent removal

• MAG3 Renogram

  3 months post stent removal

• Operative time

  Day of operation

Study Arms (1)

Versius Surgical System

EXPERIMENTAL

Device: Versius Surgical System

Interventions

Versius Surgical System DEVICE

Urological minimal access surgery performed with Versius Surgical System

Versius Surgical System

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMR Surgical Ltd: lead
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (3)

Department of Paediatric Urology, Evelina London Children's Hospital

London, SE17EH, United Kingdom

NOT YET RECRUITING

Department of Paediatric Urology Royal Manchester Children's Hospital

Manchester, M139WL, United Kingdom

NOT YET RECRUITING

Department of Paediatric Urology Southampton Children's Hospital

Southampton, SO166YD, United Kingdom

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Slack, MD

CONTACT

+44 7766 024389; mark.slack@cmrsurgical.com

Morad Nakhleh, PhD

CONTACT

+44 7518 295217; morad.nakhleh@cmrsurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 6, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)