Normal Pediatric Liver and Spleen SWE | NCT06930066

Studies
Normal Pediatric Liver and Spleen SWE

NCT06930066

Sponsor

Selcuk University

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

434Actual

Phase

Not provided

Conditions

Liver Stiffness
Spleen Stiffness
Shear Wave Elastography in Healthy Children
Normal Organ Elasticity
Pediatric Elastography

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2025Actual

Primary Completion Date

Dec 15, 2025Actual

Completion Date

Jan 30, 2026Actual

First Submitted Date

Apr 8, 2025

First Submission Date that Met QC Criteria

Apr 8, 2025

First Posted Date

Apr 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

434Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Children		This group includes healthy pediatric participants with no known liver or spleen disease. Each participant will undergo non-invasive shear wave elastography (SWE) to assess liver and spleen stiffness for the purpose of establishing normal reference values.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Normal liver and spleen stiffness values	This study aims to establish reference values for liver and spleen stiffness in healthy children using shear wave elastography (SWE).	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children aged 0-18 years
No known liver or spleen pathology
Written informed consent obtained from parents or guardians

Exclusion Criteria:

Known liver disease (e.g., hepatitis, cirrhosis)
Known spleen disease (e.g., splenomegaly)
Any history of liver or spleen disease
Age outside the 0-18 years range

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

The study population will consist of healthy children aged 0-18 years, with no known liver or spleen pathology. These participants will be selected from pediatric clinics, specifically those who are seeking routine healthy child check-ups and have no underlying diseases. Non-invasive shear wave elastography (SWE) will be used to assess normal liver and spleen stiffness values. Participants will be selected based on inclusion criteria of being free from any liver or spleen disease, and exclusion criteria will ensure that children with known hepatic or splenic conditions are not included. Parental or guardian consent will be obtained for each participant.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Selçuk University Faculty of Medicine		Konya	Konya	42130	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided