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Infant and Child European Cryoablation Project ICECaP

The ICECaP study is collecting details about a special freezing treatment, called cryoablation, for children with soft tissue problems. This treatment involves using small needles to freeze and destroy unwanted tissue. It's often seen as a gentler option than surgery, with quicker recovery and fewer scars. While cryoablation is commonly used for adults, its use in children is newer, and we don't have much information about it yet. This study will help doctors understand how effective and safe cryoablation is for children, compare results between hospitals, and ultimately help create the best guidelines for its use in young patients.

At a glance

Status
Recruiting
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Enrolment target
40
Start
24 Jun 2021
Estimated completion
01 Jul 2027

What is this study about?

The ICECaP study is looking into a treatment called cryoablation for children who have problems with their soft tissues. Soft tissues are things like muscles, fat, ligaments, and tendons – basically, anything that isn't bone. Sometimes, children can develop lumps or growths in these tissues that need treatment.

Cryoablation is a way to treat these lumps using very cold temperatures. It involves a doctor putting small needles, guided by imaging (like an ultrasound scan), through the skin into the problem area. These needles then create a freezing and thawing cycle that destroys the unwanted tissue. The good news is that this is a 'minimally invasive' procedure, meaning it doesn't involve large cuts like traditional surgery. This often means less pain, smaller scars, and a faster recovery for children.

Although cryoablation is a well-known treatment for adults, especially for certain types of kidney problems, we don't have much information yet on how widely and effectively it's being used for children in the UK. This study aims to gather all this important information. By doing so, doctors want to understand how often it works, if there are any side effects, and how different hospitals are using this treatment. Ultimately, this will help improve care for children needing this procedure across the country.

Key takeaways

  • The ICECaP study is gathering information on a freezing treatment called cryoablation for children.
  • It aims to understand how well cryoablation works and how safe it is for young patients.
  • Cryoablation is a 'minimally invasive' procedure, often with faster recovery than surgery.
  • The study helps doctors improve care for children needing this treatment.
  • Participation involves sharing medical information from your child's standard treatment.

Who may be eligible?

This study is open to all children, from babies up to 18 years old, who are going to have cryoablation for a soft tissue problem. It doesn't matter what the problem is, as long as cryoablation is being considered as a treatment.

Even if the doctors decide later that cryoablation isn't the right treatment for your child, or if they tried but couldn't perform the procedure, your child can still be included in this study. This helps researchers understand why a treatment might not go ahead or succeed.

There are no specific reasons why a child would be excluded from taking part, as long as they meet the main goal of being considered for or undergoing cryoablation. Boys and girls of all ages are welcome.

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.

  1. Is your child 18 years old or younger?
  2. Is your child being considered for or having cryoablation treatment?
  3. Is the cryoablation for a soft tissue problem (not bone, for example)?
  4. Are you happy for information about their treatment to be recorded for research?
Answer every question to see your result.

What does participation involve?

If your child is having cryoablation, their doctor will simply record information about their treatment as part of this study. This is not like a traditional clinical trial where your child would receive an experimental treatment or have many extra appointments.

Instead, the doctors will collect details about the cryoablation procedure itself, how well it worked, if there were any problems, and your child's recovery. This information is usually what doctors would record anyway as part of regular care. There are no extra tests, medications, or follow-up visits specifically for this study. The total duration of participation will depend on your child's treatment and their usual follow-up schedule.

Potential risks and benefits

Taking part in this study largely involves sharing information from your child's routine treatment. Therefore, there are no direct extra risks for your child by being in the study. The study aims to gather knowledge which could lead to better care for all children needing cryoablation in the future. As with any medical procedure, cryoablation itself carries potential risks, which your medical team will discuss with you. There are no direct benefits to your child from participating in this study, beyond contributing to medical knowledge. You always have the right to decide whether or not your child's information is included in the study, without affecting their medical care.

Locations (1)

  • Great
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is cryoablation?

Cryoablation is a treatment that uses very cold temperatures to freeze and destroy unwanted tissues, like lumps, in the body.

Is cryoablation surgery?

It's different from traditional open surgery. It's often called 'minimally invasive' because it uses small needles inserted through the skin, rather than large cuts.

Why is this study important for children?

While cryoablation is used in adults, we want to learn more about how effective and safe it is specifically for children, and how it's being used in different hospitals across the UK.

Will my child get extra tests or treatments if they join?

No, your child won't get any extra tests or treatments just for this study. The study simply collects information about their standard cryoablation procedure.

Does my child have to take part?

No, it's completely voluntary. Your decision won't affect your child's medical care in any way.

How to find out more

Alex Barnacle, BM

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

Interested in taking part?

Register your interest

Share your details and the research team for "Infant and Child European Cryoablation Project ICECaP…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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