Actively Recruiting

Age: 0 - 18Years
All Genders
ID03721783

Infant and Child European Cryoablation Project ICECaP

Led by Great Ormond Street Hospital for Children NHS Foundation Trust · Updated on 2024-10-26

40

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to collect detailed information on the use of cryoablation procedures in children with soft tissue and bone lesions. Cryoablation is a minimally invasive technique that uses image guidance to insert specialized needles or probes into lesions, applying cycles of freezing and thawing to destroy tissue. While this method is well established for adults, especially in treating kidney tumors, its use in children is still new and not well documented. The study will audit the range of applications, success rates, safety, complications, and effectiveness of cryoablation in the pediatric population. The study involves children undergoing cryoablation therapy for benign soft tissue lesions. Cryoablation uses a mechanized unit connected to probes that freeze and thaw the targeted tissue via highly pressurized gases. This process causes tissue destruction both mechanically and through immune responses. The registry collects data from multiple centers in the UK and Europe, gathering standardized information about each procedure. Data will be anonymized and entered into a web-based system for analysis. The study is open and non-controlled, focusing on repeat treatments as determined by clinical decisions. Participants will be followed for up to five years to monitor outcomes such as changes in lesion size, symptom changes, procedure failures, and any complications within two years after treatment. The registry aims to provide evidence on safety, efficacy, and best practice for pediatric cryoablation. Data will be analyzed collectively while remaining owned by individual hospitals. This will help improve treatment guidance and support future clinical trials if needed. The total participation duration varies depending on treatment and follow-up schedules.

CONDITIONS

Brief Title

Infant and Child European Cryoablation Project ICECaP

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All children in whom a clinical decision is made to treat with percutaneous cryoablation, including those where cryoablation was not technically or clinically possible at any stage
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo image-guided cryoablation therapy for soft tissue lesions.

1 procedure visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored to assess safety, lesion size changes, symptoms, and procedure outcomes over time.

Regular follow-up visits depending on clinical need and standard care

Trial Site Locations

Total: 1 location

1

Great

London, United Kingdom, WC1N 3JH

Actively Recruiting

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Research Team

A

Alex Barnacle, BM

P

Premal Patel, BM

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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