ABCA2 GIRMS Analytical Validation Clinical Performance Study

Sponsor

Cairn Diagnostics (Industry)

Overall Status

Completed

CT.gov ID

NCT04607304

Collaborator

(none)

Enrollment

Location

Arm

9.6

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Device: ABCA2 GIRMS	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection

Actual Study Start Date :

Oct 8, 2020

Actual Primary Completion Date :

Jul 27, 2021

Actual Study Completion Date :

Jul 27, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ABCA2 GIRMS

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

Device: ABCA2 GIRMS

Two systems (ABCA-C and ABCA-D) with run order randomized

Outcome Measures

Primary Outcome Measures

Diagnostic agreement at each individual timepoints [Up to 7 days per participant]
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
Percent agreement in diagnosis [Up to 7 days per participant]
Diagnosis compared between the comparative method (ABCA GIRMS) and the candidate method (ABCA2 GIRMS) at each post meal timepoint and the overall diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairn Diagnostics	Brentwood	Tennessee	United States	37027

Sponsors and Collaborators

Cairn Diagnostics

Investigators

Principal Investigator: Alex Ryder, MD, Cairn Diagnostics

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Oct 14, 2020

More Information

Publications

None provided.

Responsible Party:

Cairn Diagnostics

ClinicalTrials.gov Identifier:

NCT04607304

Other Study ID Numbers:

PRO-CD-044

First Posted:

Oct 29, 2020

Last Update Posted:

Jul 30, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Cairn Diagnostics

Gastroenterology

Gastric Emptying Breath Test

Additional relevant MeSH terms:

Gastroparesis

Study Results

No Results Posted as of Jul 30, 2021