ABCA2 GIRMS Analytical Validation Clinical Performance Study

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study the participants will be administered the FDA-approved GEBT test, which involves collecting breath samples prior to and after consumption of a non-radioactive carbon stable isotope (13C) labeled test meal. Breath samples will be collected at times consistent with FDA approved labeling. Participant's breath samples will be analyzed on the currently approved ABCA GIRMS and on the new ABCA2 GIRMS instruments. The values collected from both systems will be used to determine the clinical diagnostic agreement at each individual time points and percent agreement in diagnosis between the approved ABCA GIRMS and the new ABCA2 GIRMS.

Official Title
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ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: ABCA2 GIRMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18-85 old at time of signing the informed consent form fro healthy and intended use population participants (i.e. symptomology of gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration. Ability to eat test meal and provide breath samples Exclusion Criteria: History or physical exam suggestive of pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome History of abdominal surgery except appendectomy Use of any medications that may alter gastric motility within two days of the study Use of narcotics or anticholinergics within two days of the study Females on hormone replacement therapy other than birth control medications Receipt of an investigational drug within 4 weeks of the study Pregnancy Intolerance or allergy to any component of Gastric Emptying Breath Test meal History of neurologic or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABCA2 GIRMS<br>Leftover breath samples analyzed on ABCA2 GIRMS systems, order of analysis randomized | Device: ABCA2 GIRMS<br>* Two systems (ABCA-C and ABCA-D) with run order randomized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic agreement at each individual timepoints | Gastric emptying rates (kPCD) values compared between the validated ABCA GIRMS system and the new ABCA2 GIRMS systems for each GEBT post meal collection timepoint (45, 90, 120, 150, 180 and 240-minute timepoints) and the overall diagnosis | Up to 7 days per participant | 
| Percent agreement in diagnosis | Diagnosis compared between the comparative method (ABCA GIRMS) and the candidate method (ABCA2 GIRMS) at each post meal timepoint and the overall diagnosis | Up to 7 days per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenterology, Gastric Emptying Breath Test