Infant and Child European Cryoablation Project ICECaP
1 other identifier
observational
40
1 country
1
Brief Summary
A registry to audit the current range of applications, technical success rate, safety profile, complication rate and efficacy of cryoablation procedures being performed in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
October 26, 2024
October 1, 2024
5.6 years
October 10, 2018
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence and severity of complications arising from cryoablation treatment
Documentation and severity scoring of any complications arising from a cryoablation procedure, using the Society of Interventional Radiology (SIR) standards of practice committee classification of complications by outcome scoring system. The range of the outcome scoring system is A-F, with A being the least severe (no therapy, no consequence), and F being the most severe (resulting death). \[Omary et al. J Vasc Interv Radiol 2003; 14:S293-S295\]
2 years
Secondary Outcomes (3)
Change in maximal diameter of lesion following treatment
5 years
Change in symptomatology following treatment
2 years
Procedure failure
3 years
Study Arms (1)
children with soft tissue lesions
All children who undergo cryoablation therapy for benign soft tissue lesions
Interventions
Image guided cryoablation therapy of soft tissue lesions
Eligibility Criteria
All children in whom a clinical decision is made to treat with percutaneous cryoablation
You may qualify if:
- all children in whom a clinical decision is made to treat with percutaneous cryoablation, to include those in whom cryoablation was not technically or clinically possible at any stage.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Great
London, WC1N 3JH, United Kingdom
Related Publications (1)
Shaikh R, Alomari AI, Kerr CL, Miller P, Spencer SA. Cryoablation in fibro-adipose vascular anomaly (FAVA): a minimally invasive treatment option. Pediatr Radiol. 2016 Jul;46(8):1179-86. doi: 10.1007/s00247-016-3576-0. Epub 2016 Feb 22.
PMID: 26902298RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Barnacle, BM
Great Ormond Street Hospital, London, UK
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2018
First Posted
October 26, 2018
Study Start
June 24, 2021
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
October 26, 2024
Record last verified: 2024-10