Effect of Thoracic Diameter and Food Intake on Fibroscan® Results
FS
1 other identifier
interventional
53
1 country
1
Brief Summary
The study aims to deliver scientific data regarding the accuracy of the two different-sized Fibroscan® probes on patients with different thoracic diameter to gain more knowledge of the handling and measuring quality of the Fibroscan® as a diagnostic device and also to see if one probe is enough to measure a wider spectrum of patients leading to cost reduction for equipment such as additional probes. Furthermore the study aims to analyze the effect of food intake on liver-stiffness measurements with the S-probe on children to shorten fasting periods. It is hypothesized that the fasting periods before a Fibroscan® measurement may be shortened, which is of special importance in smaller children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 5, 2021
February 1, 2021
5 months
May 9, 2019
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Liver stiffness
Comparison of liver stiffness measurements at baseline with M- and S- probe
baseline
Secondary Outcomes (4)
Liver stiffness
120 minutes
Liver stiffness
120 minutes
Liver fat content
baseline
Liver fat content
120 minutes
Study Arms (2)
Participants with a thoracic diameter < 75 cm
OTHERMeasurement of liver stiffness before and after a standardized meal with different probes
Participants with a thoracic diameter >75 cm
OTHERMeasurement of liver stiffness before and after a standardized meal with different probes
Interventions
Measurement of liver stiffness
Measurement of liver stiffness
Eligibility Criteria
You may qualify if:
- Age \> 18 for the adult Population
- Age 11-18 for the paediatric population
- Informed consent
- No history of liver disease
- Thoracic diameter \>45 cm
You may not qualify if:
- Acute or chronic liver disease
- Any other disease or circumstance that may impact on the result of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Graz
Graz, Austria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 13, 2019
Study Start
June 1, 2019
Primary Completion
October 19, 2019
Study Completion
December 31, 2020
Last Updated
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share