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Assessing Portal Hypertension With Methacetin Breath Test

NCT02143778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2022-12-20

Study results available
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Summary

This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg,

Conditions

  • Patients With Compensated Liver Cirrhosis

Interventions

DEVICE

Methacetin Breath Test

13C labelled methacetin solution for breath test monitoring

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Juan Carlos Garcia Pagan, MD · University Hospital Barcelona

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-12-31
Completion
2019-01-31

Countries

  • United States
  • France
  • Spain
  • Switzerland

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 NCT02143778 on ClinicalTrials.gov