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Clinical Trials in Sweden / NCT05686785
Recruiting Observational

Agreement and Reliability of Transient Elastography

NCT05686785 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lund University
Phase
Observational
Started
2023-06-01
Last updated
2023-10-04

Condition(s) studied

Chronic Viral Hepatitis

Investigational drug(s) / intervention(s)

Transient elastography

Transient elastography: Transient elastography measures liver stiffness in kPa

Study summary

The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients at the departments of infectious diseases in Malmö, Lund and Helsingborg with chronic viral hepatitis. * Adult patients * Signed informed consent to participate in the study. Exclusion Criteria: * suspected or confirmed pregnancy. * patients unable to speak Swedish * inability to sign informed consent.

Primary outcome measure(s)

  • Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95. — Assessed at a 30 min visit to the outpatient clinic
    Disagreement, expressed as 1) the proportion of participants with inter-rater differences at or above our prespecified threshold (33%) and 2) the smallest detectable change, representing the difference needed to state with 95% certainty that a change had occurred in the underlying fibrosis (SDC95).

Trial sites (1)

FacilityCityRegionStatus
Oskar Ljungquist Helsingborg Skåne County Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05686785 on ClinicalTrials.gov ↗ ← All trials in Sweden