Robot surgeon for kids: versius system put to the test in pediatric urology
NCT ID NCT06539442
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing whether the Versius robotic surgical system is safe and effective for urological operations in children and teenagers under 18. The study enrolls 150 young patients across multiple hospitals and uses a step-by-step approach, starting with a few cases to check for unexpected problems before expanding. The goal is to see how often adverse events occur and how well the robot completes procedures without needing to switch to open surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Versius Surgical System, a robotic device used to perform minimally invasive urological surgery
- What this could lead to
- If it works, children needing urological surgery could have a minimally invasive robotic option that may mean smaller cuts and faster recovery.
- What could go wrong
- This is an early feasibility study with no control group, so safety and success rates in children remain unproven. Robotic surgery carries risks of bleeding, infection, or the need to switch to open surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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150 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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0 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Contacts and locations
Locations
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Department of Paediatric Urology Royal Manchester Children's Hospital
Manchester, M139WL, United Kingdom
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Department of Paediatric Urology Southampton Children's Hospital
Southampton, SO166YD, United Kingdom
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Department of Paediatric Urology, Evelina London Children's Hospital
London, SE17EH, United Kingdom