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Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)

NCT07222813 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-10-30

No results posted yet for this study

Summary

This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.

Conditions

Interventions

BIOLOGICAL

Blood Sample Analysis

At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests

DEVICE

FibroScan

At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)

PROCEDURE

Right-sided Heart Catheterization

at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)

PROCEDURE

Transthoracic echocardiography

at Day 0 assessment of cardiac function

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-12-31
Completion
2027-01-15
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222813 on ClinicalTrials.gov