Optimization of Spleen VCTE Examinations with FibroScan
NCT ID: NCT05122416
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
433 participants
INTERVENTIONAL
2022-06-01
2024-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1a: SSD<15mm and with splenomegaly
Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.
FibroScan examination (S)
A FibroScan examination with the Exploratory S probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Group 1b: SSD<15mm and without splenomegaly
Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.
FibroScan examination (S)
A FibroScan examination with the Exploratory S probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Group 2a : 15<SSD<25mm and with splenomegaly
Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.
FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Group 2b : 15<SSD<25mm and without splenomegaly
Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.
FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Group 3.1.a: SSD≥25mm and with splenomegaly
Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.
FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Group 3.1.b: SSD≥25mm and without splenomegaly
Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.
FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
3.2 Patient with BMI >or = to 35kg/m²
Patients with a Spleen to Skin Distance higher than 25 mm and BMI \> or = to 35kg/m².
FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Interventions
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FibroScan examination (S)
A FibroScan examination with the Exploratory S probe.
FibroScan examination (M)
A FibroScan examination with the Optimized M probe.
FibroScan examination (XL)
A FibroScan examination with the Exploratory XL probe.
FibroScan examination (Standard M)
A FibroScan examination with the Standard M probe.
Eligibility Criteria
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Inclusion Criteria
2. Patient affiliated to the healthcare system
3. Adult or children patient followed for a liver disease a suspicion of liver disease or for a consequence of a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam.
Exclusion Criteria
2. Patients with ascites
ALL
No
Sponsors
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Echosens
INDUSTRY
Responsible Party
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Principal Investigators
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Robert de Knegt, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Rotterdam
Locations
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University Medical Center Rotterdam
Rotterdam, , Netherlands
Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)
Cluj-Napoca, , Romania
Hospital Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Other Identifiers
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M139
Identifier Type: -
Identifier Source: org_study_id
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