ABCA2 GIRMS Analytical Validation Clinical Performance Study

Cairn Diagnostics

Status: Completed

Conditions: Gastroparesis

Treatments: Device: ABCA2 GIRMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04607304

PRO-CD-044

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

ABCA2 GIRMS

Experimental group

Description:

Leftover breath samples analyzed on ABCA2 GIRMS systems, order of analysis randomized

Treatment:

Device: ABCA2 GIRMS