Liver and the Spleen Stifness in Adult Patients With Gaucher's Disease Using Ultrasound Shear Wave Elastography

NCT ID: NCT03896607

Last Updated: 2023-03-06

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-30

Study Completion Date

2022-10-31

Brief Summary

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The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher Disease(GD) by using Shear Wave Elastography- SWE to evaluation fibrosis of the tissue and to check the correlation of fibrosis with the biomarkers of disease severity.

Detailed Description

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To assess liver and spleen stiffness measurement using Shear Wave Elastography-SWE and evaluate liver and spleen fibrosis in patients with Gaucher Disease. To compare the elastography with the biomarkers that taken at the GD haematology clinic and to check the correlation with severity of liver and spleen fibrosis.

SWE is a safe with diagnostic accuracy regarding the liver (\& Spleen) fibrosis. Estimating spleen fibrosis is an innovative approach in liver disease and Gaucher.

The evaluation of fibrosis with this relatively new and safe method could avoid complications and invasive procedure in GD patients .

Conditions

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Gaucher Disease Liver Fibrosis Spleen; Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients with Gaucher disease over the age of 18 years.
2. Patients able to sign informed consent form.
3. Women are not pregnant.
4. Patients who read and understood the contents of the consent form and gave their written consent to participate in the study.

Exclusion Criteria

1. Participants under the age of 18.
2. Pregnant women.
3. Participants are unable to sign an informed consent form.
4. Participants with known liver disease not associated with Gaucher disease such as liver cirrhosis, patients with HBV, HBC or liver cirrhosis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Ziv Neeman

Head of Radiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ziv neeman, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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HaEmek Medical Center

Afula, Northern District, Israel

Site Status

Countries

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Israel

Other Identifiers

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0135-18-EMC

Identifier Type: -

Identifier Source: org_study_id

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