Optimization of Spleen VCTE Examinations with FibroScan

Last updated: January 13, 2025
Sponsor: Echosens
Overall Status: Terminated

Phase

N/A

Condition

Scar Tissue

Treatment

FibroScan examination (XL)

FibroScan examination (M)

FibroScan examination (Standard M)

Clinical Study ID

NCT05122416
M139
  • All Genders

Study Summary

This is an European, prospective, interventional, and multicenter clinical investigation which main objective is to develop a spleen examination dedicated to overweight or obese patients and assess its applicability. It will take place in 4 sites (1 site in the Netherlands, 2 sites in Spain and 1 site in Romania) to include a total of 500 patients (adults and children).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult or pediatric patient able to give written informed consent (parents/legaltutors in case of minor patients),

  2. Patient affiliated to the healthcare system

  3. Adult or children patient followed for a liver disease a suspicion of liver diseaseor for a consequence of a liver disease, with or without splenomegaly and having aspleen to skin distance (SSD) measurement performed during the screening ultrasoundexam.

Exclusion

Exclusion Criteria:

  1. Vulnerable patient- other than pediatric patients

  2. Patients with ascites

Study Design

Total Participants: 433
Treatment Group(s): 4
Primary Treatment: FibroScan examination (XL)
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
November 22, 2024

Connect with a study center

  • University Medical Center Rotterdam

    Rotterdam,
    Netherlands

    Site Not Available

  • Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)

    Cluj-Napoca,
    Romania

    Site Not Available

  • Hospital Puerta de Hierro Majadahonda

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

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