NCT04607304

ABCA2 GIRMS Analytical Validation Clinical Performance Study

ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Cairn Diagnostics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	ABCA2 GIRMS	Two systems (ABCA-C and ABCA-D) with run order randomized

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-07-27
• Completion: 2021-07-27
• First posted: 2020-10-29
• Last updated: 2021-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study