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BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Study:

Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

Rationale:

n/a

Purpose:

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.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Chronic Liver Disease Device: c13 methacetin solution with breath analyzer Phase 3

Verified by Exalenz Bioscience LTD. February, 2012

Sponsored by: Exalenz Bioscience LTD.
Information provided by: Exalenz Bioscience LTD.
ClinicalTrials.gov identifier: NCT00736840

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Cleveland Clinic
Cleveland, Ohio 44195
United States

Stuart Gordon, MD., Principal Investigator
Adrian Rueben, MD., Principal Investigator
Gadi Lalazar, MD., Principal Investigator
Arun Sanyal, MD., Principal Investigator
Fred Poordad, MD., Principal Investigator
K Rajender Reddy, MD., Principal Investigator
Zobair Younossi, MD., Principal Investigator
Arthur McCullough, MD., Principal Investigator
John Vierling, MD., Principal Investigator
Alexander Fich, MD., Principal Investigator
Eli Zuckerman, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.