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NCT02860884 Clinical Trial

Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

Non-alcoholic Fatty Liver Disease Clinical Trial

— NASH  

Official title:
Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02860884
Other study ID # 35RC13_8989
Secondary ID
Status Completed
Phase N/A
First received July 26, 2016
Last updated August 4, 2016
Start date August 2014
Est. completion date October 2015

Study information
Verified date July 2016
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH

Recruitment information / eligibility
Status Completed
Enrollment 136
Est. completion date October 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank

- Men or Women

- aged of 18 years or more

- After giving their consent to participate in research

Exclusion Criteria:

- Known Cancer

- Refusal of consent

- Inflammatory disease

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• liver biopsy

Other:
• infrared spectroscopy

Locations
Country Name City State
France Centre hospitalier universitaire de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity Evaluation of the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH with liver biopsy as a gold standard through study completion, an average of 1 year No
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