Back to resultsABCA2 GIRMS Analytical Validation Clinical Performance Study
Primary Purpose
Gastroparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABCA2 GIRMS
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroparesis focused on measuring Gastroenterology, Gastric Emptying Breath Test
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
Sites / Locations
- Cairn Diagnostics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABCA2 GIRMS
Arm Description
Leftover breath samples analyzed on ABCA2 GIRMS systems, order of analysis randomized
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04607304
Brief Title
ABCA2 GIRMS Analytical Validation Clinical Performance Study
Official Title
ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
July 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cairn Diagnostics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroenterology, Gastric Emptying Breath Test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABCA2 GIRMS
Arm Type
Experimental
Arm Description
Leftover breath samples analyzed on ABCA2 GIRMS systems, order of analysis randomized
Intervention Type
Device
Intervention Name(s)
ABCA2 GIRMS
Intervention Description
Two systems (ABCA-C and ABCA-D) with run order randomized
Primary Outcome Measure Information:
Title
Diagnostic agreement at each individual timepoints
Description
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
Time Frame
Up to 7 days per participant
Title
Percent agreement in diagnosis
Description
Diagnosis compared between the comparative method (ABCA GIRMS) and the candidate method (ABCA2 GIRMS) at each post meal timepoint and the overall diagnosis
Time Frame
Up to 7 days per participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Ryder, MD
Organizational Affiliation
Cairn Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairn Diagnostics
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ABCA2 GIRMS Analytical Validation Clinical Performance Study
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