Versius Paediatrics Study

Last updated: October 9, 2024
Sponsor: CMR Surgical Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Versius Surgical System

Clinical Study ID

NCT06539442
CA-00533
  • Ages < 17
  • All Genders

Study 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

Inclusion Criteria:

  • Patients, male or female, (<18 years old) for whom an appropriate legalrepresentative 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 participatingcentres

Exclusion

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 primaryobjectives 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 whichwould contra-indicate a surgical procedure

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Versius Surgical System
Phase:
Study Start date:
July 08, 2024
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Department of Paediatric Urology, Evelina London Children's Hospital

    London, SE17EH
    United Kingdom

    Site Not Available

  • Department of Paediatric Urology Royal Manchester Children's Hospital

    Manchester, M139WL
    United Kingdom

    Site Not Available

  • Department of Paediatric Urology Southampton Children's Hospital

    Southampton, SO166YD
    United Kingdom

    Active - Recruiting

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