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Optimization of Spleen VCTE Examinations with FibroScan

NCT05122416 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2025-01-15

No results posted yet for this 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).

Conditions

  • Spleen; Fibrosis

Interventions

DEVICE

FibroScan examination (S)

A FibroScan examination with the Exploratory S probe.

DEVICE

FibroScan examination (M)

A FibroScan examination with the Optimized M probe.

DEVICE

FibroScan examination (XL)

A FibroScan examination with the Exploratory XL probe.

DEVICE

FibroScan examination (Standard M)

A FibroScan examination with the Standard M probe.

Sponsors & Collaborators

  • Echosens

    lead INDUSTRY

Principal Investigators

  • Robert de Knegt, PhD · University Medical Center Rotterdam

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-11-22
Completion
2024-11-22

Countries

  • Netherlands
  • Romania
  • Spain

Study Locations

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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 NCT05122416 on ClinicalTrials.gov