Robotic Surgical Procedures in Pediatric UrologyNCT06539442
Versius Paediatrics Study
A study testing Versius Surgical System in people with Robotic Surgical Procedures in Pediatric Urology, run by CMR Surgical Ltd at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Robotic Surgical Procedures in Pediatric Urology
- What is being tested?
- Versius Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 8 Jul 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Department of Paediatric Urology, Evelina London Children's Hospital
London, SE17EH
Department of Paediatric Urology Royal Manchester Children's Hospital
Manchester, M139WL
Department of Paediatric Urology Southampton Children's Hospital
Southampton, SO166YD
About this study
Official title: Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
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.
- Being tested
- Versius Surgical System
- Keywords
- Pediatric, Paediatric, Versius, Urology, Robotic assisted surgery, minimal access surgery, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versius Surgical SystemDevice
Urological minimal access surgery performed with Versius Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Versius Surgical System | Experimental | Not described Receives: Device: Versius Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event rate
Incidence of adverse events
Measured: Up to 3 months post operation
Secondary outcomes (12)
Procedure completion
Rate of successful completion of procedures without unplanned conversion to other laparoscopic or open surgery
Measured: Day of operation
Serious Adverse Event Rate
Incidence of serious adverse events
Measured: Up to 3 months post-operation
Ultrasound grading
Ultrasound hydronephrosis grading results
Measured: 3 months post stent removal
MAG3 Renogram
MAG3 Renogram results
Measured: 3 months post stent removal
Operative time
Surgery duration from skin incision to skin closure in minutes
Measured: Day of operation
Blood loss
Estimated blood loss in mL
Measured: Day of operation
Post operative analgesic treatment
Pain medication prescribed post-operatively
Measured: Immediately after surgery
Length of stay
Hospital stay from end of surgery to discharge in days
Measured: Up to 3 months post operation, average 1 day
Reoperation
Reoperation within 24 hours of surgery
Measured: 24 hours post operation
Unplanned readmission
Unplanned hospital readmissions
Measured: Up to 3 months post operation
Device deficiencies and user errors
Device deficiencies and user errors that occur during surgery
Measured: Day of operation
Ultrasound grading
Ultrasound hydronephrosis grading results
Measured: 12 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start8 Jul 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical Procedures in Pediatric UrologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMR Surgical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ewan Brownlee, MD, Principal investigator, Department of Paediatric Urology Southampton Children's HospitalDavid Keene, MD, Principal investigator, Department of Paediatric Urology Royal Manchester Children's HospitalPankaj Mishra, MD, Principal investigator, Department of Paediatric Urology, Evelina London Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539442
- Sponsor's protocol ID
- CA-00533
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Urological Procedures in Paediatrics
- ClinicalTrials.gov ID
- NCT06539442
- Acronym / sponsor ID
- CA-00533
- Keywords
- Pediatric, Paediatric, Versius, Urology, Robotic assisted surgery, minimal access surgery, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CMR Surgical LtdIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Versius Surgical System | Experimental | Device: Versius Surgical System |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versius Surgical SystemUrological minimal access surgery performed with Versius Surgical System | Device | Versius Surgical System |
Primary outcome
Adverse Event rate
Time frame: Up to 3 months post operation
Incidence of adverse events
12 secondary outcomes
Procedure completion
Time frame: Day of operation
Serious Adverse Event Rate
Time frame: Up to 3 months post-operation
Ultrasound grading
Time frame: 3 months post stent removal
MAG3 Renogram
Time frame: 3 months post stent removal
Operative time
Time frame: Day of operation
Blood loss
Time frame: Day of operation
Post operative analgesic treatment
Time frame: Immediately after surgery
Length of stay
Time frame: Up to 3 months post operation, average 1 day
Reoperation
Time frame: 24 hours post operation
Unplanned readmission
Time frame: Up to 3 months post operation
Device deficiencies and user errors
Time frame: Day of operation
Ultrasound grading
Time frame: 12 months post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewan Brownlee, MD principal investigator
Department of Paediatric Urology Southampton Children's Hospital
David Keene, MD principal investigator
Department of Paediatric Urology Royal Manchester Children's Hospital
Pankaj Mishra, MD principal investigator
Department of Paediatric Urology, Evelina London Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Versius Surgical System in people with Robotic Surgical Procedures in Pediatric Urology, run by CMR Surgical Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event rate (time frame: Up to 3 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.