ABCA2 GIRMS Analytical Validation Clinical Performance Study

Gastroparesis Clinical Trial

Official title:

ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607304
• Other study ID #: PRO-CD-044
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: July 27, 2021

Study information

• Verified date: July 2021
• Source: Cairn Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• ABCA2 GIRMS
Two systems (ABCA-C and ABCA-D) with run order randomized

Locations

Country	Name	City	State
United States	Cairn Diagnostics	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cairn Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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