ABCA2 GIRMS Analytical Validation Clinical Performance Study - Trial NCT04607304
Access comprehensive clinical trial information for NCT04607304 through Pure Global AI's free database. This phase not specified trial is sponsored by Cairn Diagnostics and is currently Completed. The study focuses on Gastroparesis. Target enrollment is 95 participants.
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Study Focus
Sponsor & Location
Cairn Diagnostics
Timeline & Enrollment
N/A
Oct 08, 2020
Jul 27, 2021
Primary Outcome
Diagnostic agreement at each individual timepoints,Percent agreement in diagnosis
Summary
The purpose of this study is to collect human breath samples for use in a validation study
 intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS
 (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio Mass Spectrometer) instruments to the
 currently FDA-approved ABCA GIRMS (Automated Breath Carbon Analyzer Gas Isotope Ratio Mass
 Spectrometer) system. ABCA GIRMS systems are used to analyze the ratio of 13CO2 to 12CO2 in
 patient breath samples during the GEBT (Gastric Emptying Breath Test) procedure.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04607304
Device Trial