RecruitingNAINTERVENTIONAL

Versius Paediatrics Study

This study is exploring a new way to perform operations on children with conditions affecting their urinary system (like kidneys and bladder). It uses a special robot called Versius to assist surgeons. The main goal is to see if using this robot for children's operations is safe and effective. It's a step-by-step study, starting with a small number of procedures to make sure everything is working as expected. If found safe, more children will join the study. This research is important because it could lead to less invasive and potentially better ways to treat young patients needing surgery for these conditions. The study is for children under 18 and aims to gather evidence over time.

At a glance

Status

Recruiting

Phase

Sponsor

CMR Surgical Ltd

Enrolment target

150

Start

08 Jul 2024

Estimated completion

01 Jan 2027

Robotic Surgical Procedures in Pediatric Urology

What is this study about?

This study, called the Versius Paediatrics Study, is looking into using a special surgical robot called Versius to perform operations on children and teenagers up to 17 years old. The operations are for conditions affecting their urinary system, which includes organs like the kidneys and bladder.

The main aim is to find out if this robotic way of operating is safe and works well for young patients. It's an important step to see if this technology can offer benefits for children needing these types of operations. The study is designed in phases, meaning it starts small to ensure safety before involving more patients. This careful approach helps doctors understand how best to use the robot and if it's a good option for children's surgery.

First, a very small number of operations will be done at one hospital to check for any unexpected problems. If these initial operations prove to be safe, then a few more will be carried out at the same hospital. Once doctors are confident in the safety, the study will expand to include more children at different hospitals. Throughout the study, doctors will keep a close eye on the children's well-being and recovery, just as they would with any standard care.

Key takeaways

This study uses a robot (Versius) for children's urinary system operations.
It aims to check if robotic surgery is safe and effective for young patients.
The study is for children and teenagers under 18 years old.
Participation will not change your child's standard medical care or follow-up.
It's a step-by-step study beginning with a small number of cases to ensure safety.
Families can choose to withdraw from the study at any time.

Who may be eligible?

To be part of this study, a child must be under 18 years old. Their parent or legal guardian needs to give their permission in writing. Doctors must also agree that a keyhole operation for their urinary condition is suitable for them, and that treatment with surgery is the best plan.

There are some reasons why a child might not be able to join. These include being 18 or older, or if a parent or guardian doesn't want them to take part. Also, if a child cannot have a general anaesthetic or a keyhole operation for health reasons, they won't be able to participate. Pregnant teenagers, or those with very high obesity, or if they have had certain types of previous medical treatments, like radiotherapy in their tummy area, would also not be able to join. Finally, if they are already in another clinical study that might affect the results of this one, or have other serious health problems, they might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child under 18 years old?
Are you, as their parent or legal guardian, willing to give written permission?
Has their medical team decided a keyhole operation is suitable for their urinary condition?
Can your child safely have a general anaesthetic and keyhole surgery?
Has your child not had radiotherapy to their tummy or pelvis in the past?
Is your child not currently in another medical research study that might get in the way of this one?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive their surgery using the Versius robotic system, as decided by their medical team. After the operation, their care and follow-up will be just like any other child having this type of surgery at the hospital. This means regular check-ups to make sure they are recovering well. The study itself won't add any extra visits or changes to the standard medical care your child would already receive for their condition. The doctors will simply be carefully recording information about the robotic surgery and your child's recovery to understand how well the Versius system works.

Potential risks and benefits

Any surgery carries potential risks, and using a new surgical tool like a robot also has potential, though often small, risks, such as unexpected problems during the procedure. However, a potential benefit of robotic surgery could be more precise operations, which might lead to quicker recovery times or less discomfort for some children, though this is what the study aims to explore. You and your child's legal guardian have the right to withdraw from the study at any time, for any reason, without affecting your child's medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Department of Paediatric Urology, Evelina London Children's Hospital
Verified postcode
London, United Kingdom· Not yet recruiting
Department of Paediatric Urology Royal Manchester Children's Hospital
Verified postcode
Manchester, United Kingdom· Not yet recruiting
Department of Paediatric Urology Southampton Children's Hospital
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is the Versius robot?

The Versius robot is a special machine that helps surgeons perform operations. It's designed to give surgeons more precision and flexibility.

Will my child's medical care change if they join?

No, your child will receive the same high standard of care and follow-up as any other child having this type of surgery. The study mainly observes the use of the robotic system.

What kinds of operations will the robot be used for?

It will be used for keyhole operations on conditions affecting children's kidneys, bladder, and other parts of their urinary system.

Who is paying for this study?

The information provided doesn't specify who is funding the study, but clinical trials are typically funded by research organisations, hospitals, or medical device companies.

Can we stop participating if we change our minds?

Yes, you can withdraw your child from the study at any point without it affecting their medical treatment now or in the future.

How to find out more

Mark Slack, MD

mark.slack@cmrsurgical.com +44 7766 024389 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.