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BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

NCT00736840 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2023-01-12

Study results available
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Summary

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Conditions

Interventions

DEVICE

c13 methacetin solution with breath analyzer

Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Gordon, MD · Henry Ford Health System

  • Adrian Rueben, MD · Medical University of South Carolina

  • Gadi Lalazar, MD · Hadassah Medical Organization

  • Arun Sanyal, MD · Virginia Commonwealth University

  • Fred Poordad, MD · Cedars Sinai Health System

  • K Rajender Reddy, MD · University of Pennsylvania Health System

  • Zobair Younossi, MD · Inova Health Care Services

  • Arthur McCullough, MD · The Cleveland Clinic

  • John Vierling, MD · St. Luke's Episcopal Hospital, Baylor College of Medicine

  • Alexander Fich, MD · Soroka University Medical Center

  • Eli Zuckerman, MD · Carmel Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT00736840 on ClinicalTrials.gov