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Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery

NCT03294850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-07-16

Study results available
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Summary

The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.

Conditions

  • NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease

Interventions

PROCEDURE

Bariatric surgery

Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied

DEVICE

HepQuant SHUNT Dual Cholate Liver Diagnostic Kit

For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.

Sponsors & Collaborators

  • AdventHealth Translational Research Institute

    lead OTHER

Principal Investigators

  • Steven Smith, MD · Study Principal Investigator

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2019-11-14
Completion
2020-09-11
FDA Device
Yes

Countries

  • United States

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 NCT03294850 on ClinicalTrials.gov