Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-29 @ 6:29 PM
Study NCT ID:
NCT06930066
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Pediatric Liver and Spleen SWE
Sponsor:
Selcuk University
Organization:
Study Overview
Official Title:
Normal Liver and Spleen Stiffness Values Using Shear Wave Elastography in Children
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWE
Brief Summary:
This observational study aims to determine normal liver and spleen stiffness values in healthy children using shear wave elastography (SWE). The study will include participants from the pediatric age group without known liver or spleen disease. SWE measurements will be performed non-invasively to establish reference values. The results may contribute to improving diagnostic accuracy in pediatric elastography applications.
Detailed Description:
Shear wave elastography (SWE) is a non-invasive imaging method used to assess tissue stiffness. While reference values for SWE have been established in adults, data regarding normal liver and spleen stiffness in children are limited. This single-center, cross-sectional observational study aims to establish normative SWE values for the liver and spleen in the pediatric age group. Children with no known liver or spleen pathology will undergo standardized SWE measurement under controlled conditions. Age-specific and sex-specific reference ranges will be analyzed, which may contribute to enhancing the clinical utility of SWE in pediatric practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: