Versius Paediatrics Study

NCT ID: NCT06539442

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Versius Surgical System

Group Type: EXPERIMENTAL

Versius Surgical System

Intervention Type: DEVICE

Urological minimal access surgery performed with Versius Surgical System

Interventions

Versius Surgical System

Urological minimal access surgery performed with Versius Surgical System

Intervention Type: DEVICE

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

CMR Surgical Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ewan Brownlee, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatric Urology Southampton Children's Hospital

David Keene, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatric Urology Royal Manchester Children's Hospital

Pankaj Mishra, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatric Urology, Evelina London Children's Hospital

Locations

Department of Paediatric Urology, Evelina London Children's Hospital

London, , United Kingdom

Site Status: NOT_YET_RECRUITING

Department of Paediatric Urology Royal Manchester Children's Hospital

Manchester, , United Kingdom

Site Status: NOT_YET_RECRUITING

Department of Paediatric Urology Southampton Children's Hospital

Southampton, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Mark Slack, MD

Role: CONTACT

mark.slack@cmrsurgical.com

+44 7766 024389

Morad Nakhleh, PhD

Role: CONTACT

morad.nakhleh@cmrsurgical.com

+44 7518 295217

Facility Contacts

Pankaj Mishra, MD

Role: primary

David Keene, MD

Role: primary

Ewan Brownlee, MD

Role: primary

Other Identifiers

CA-00533

Identifier Type: -

Identifier Source: org_study_id