Clinical trial NCT04607304: ABCA2 GIRMS Analytical Validation Clinical Performance Study
Official title: ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroenterology
Gastric Emptying Breath Test
Lead sponsor: Cairn Diagnostics
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic agreement at each individual timepoints
timeFrame: Up to 7 days per participant
measure: Percent agreement in diagnosis
timeFrame: Up to 7 days per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: Cairn Diagnostics
state: Tennessee
Study officials:
affiliation: Cairn Diagnostics
name: Alex Ryder, MD
role: PRINCIPAL_INVESTIGATOR
References: