NCT05567328

Brief Summary

This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

October 26, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

September 26, 2022

Last Update Submit

January 13, 2025

Conditions

Liver Diseases

Keywords

FibroScanVibration Control Transient ElastographyVibration Guided Transient ElastographyLiver Stiffness MeasurementVCTEVGTE

Outcome Measures

Primary Outcomes (1)

  • Difference of patient percentage having a successful examination between the novel and the reference FibroScan examination

    To compare the applicability between the novel FibroScan and the reference FibroScan examination performed on the liver

    17 months

Secondary Outcomes (9)

  • Difference of success rate between the novel and the reference FibroScan examination

    17 months

  • Difference between the initial localization durations required for the novel and the reference FibroScan examination.

    17 months

  • Difference between the examination durations required for the novel and the reference examination based on liver stiffness measurements.

    17 months

  • Difference between the examination durations required for the novel and the reference examination based on CAP measurements.

    17 months

  • Intraclass Correlation Coefficient (ICC) between novel and reference FibroScan examinations

    17 months

  • +4 more secondary outcomes

Study Arms (1)

Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined

EXPERIMENTAL

Adult patients followed in the Hepatology or Endocrinology department for a liver disease, all etiologies combined.

Device: Research FibroScan (FS)

Interventions

Research FibroScan (FS)DEVICE

Exams will be performed with the M or XL probe as per FS recommendations. Same probe must be used for all exams Exploratory exam after patient 151 are performed with adapted view of Research FS Patients 1 to 90 \& 151 to 190 Exam1 Exploratory exam with the Research FS Exam2 Reference exam with the CE-marked FS Patients 91 to 130 \& 191 to 230 Exams1\&2 Two consecutive Exploratory exams with the Research FS Exams3\&4 Two consecutive Reference exams with the CE-marked FS Patients 131 to 150 Exams1\&2 Two consecutive Exploratory exams with automatic function of the Research FS Exam3 Reference exam with the CE-marked FS Patients 231 to 270 Exams1 (novice operator) Exploratory exam with the Research FS Exams2 (novice operator) Reference exam with the CE-marked FS Exams3 (experienced/expert operator) Exploratory exam with the Research FS Exams4 (experienced/expert operator) Reference exam with the CE-marked FS

Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age \> = 18 years old) followed for a liver disease; a suspicion of liver disease or for consequences of liver disease, all etiologies combined
  • Patient must be able to give written informed consent
  • Patient affiliated to a social security system

You may not qualify if:

  • Vulnerable patient
  • Patients with ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Beaujon

Clichy, 92110, France

Location

Hospices Civils de Lyon - Lyon Sud

Lyon, 69495, France

Location

CHU de Nancy

Nancy, France

Location

Related Publications (1)

  • Bastard C, Audiere S, Foucquier J, Loree H, Miette V, Bronowicki JP, Stern C, Caussy C, Sandrin L. Guided-VCTE: An Enhanced FibroScan Examination With Improved Guidance and Applicability. Ultrasound Med Biol. 2025 Apr;51(4):628-637. doi: 10.1016/j.ultrasmedbio.2024.12.007. Epub 2025 Jan 13.

    PMID: 39809636DERIVED

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 5, 2022

Study Start

October 26, 2022

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations

FR(3)