NCT02143778

Assessing Portal Hypertension With Methacetin Breath Test

Clinical Study of the BreathID® LF System to Train the Algorithm for the ¹³C-Methacetin Breath Test (MBT) in Assessment of Portal Hypertension in Patients With Compensated Liver Cirrhosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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,

Detailed description

The portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.

Conditions

• Patients With Compensated Liver Cirrhosis

Interventions

Type	Name	Description
DEVICE	Methacetin Breath Test	13C labelled methacetin solution for breath test monitoring

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2014-05-21
• Last updated: 2022-12-20
• Results posted: 2019-09-19

Locations

8 sites across 4 countries: United States, France, Spain, Switzerland