Versius Paediatrics Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorCMR Surgical Ltd

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients ≥ 18 years old

Appropriate legal representative unwilling to provide written consent

Medical contraindication for general anaesthesia

Medical contraindication for laparoscopic procedure

Trial design

Design model

Single group

Treatments tested in this trial

  • Versius Surgical System

    Device

    Urological minimal access surgery performed with Versius Surgical System

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Versius Surgical SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Event rate

Incidence of adverse events

Time frame
Up to 3 months post operation

Secondary outcomes

1

Procedure completion

Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery

Time frame
Day of operation
2

Serious Adverse Event Rate

Incidence of serious adverse events

Time frame
Up to 3 months post-operation
3

Ultrasound grading

Ultrasound hydronephrosis grading results

Time frame
3 months post stent removal
4

MAG3 Renogram

MAG3 Renogram results

Time frame
3 months post stent removal

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CMR Surgical Ltd

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Collaborator