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Prospective clinical study to assess the safety and efficacy of versius, in urological procedures in paediatrics

NCT ID NCT06539442

NEW Sponsor: CMR Surgical Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

150 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Robotic surgical procedures in pediatric urology

Contacts and locations

Locations

  • Department of Paediatric Urology Royal Manchester Children's Hospital

    Manchester, M139WL, United Kingdom

  • Department of Paediatric Urology Southampton Children's Hospital

    Southampton, SO166YD, United Kingdom

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

    London, SE17EH, United Kingdom