ABCA2 GIRMS Analytical Validation Clinical Performance Study | NCT04607304

Studies
ABCA2 GIRMS Analytical Validation Clinical Performance Study

NCT04607304

Sponsor

Cairn Diagnostics

Status

Completed

Last Update Posted

Jul 30, 2021Actual

Enrollment

95Actual

Phase

Not Applicable

Conditions

Gastroparesis

Interventions

ABCA2 GIRMS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2020Actual

Primary Completion Date

Jul 27, 2021Actual

Completion Date

Jul 27, 2021Actual

First Submitted Date

Oct 18, 2020

First Submission Date that Met QC Criteria

Oct 22, 2020

First Posted Date

Oct 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Jul 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABCA2 GIRMS	Experimental	Leftover breath samples analyzed on ABCA2 GIRMS systems, order of analysis randomized	Device: ABCA2 GIRMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABCA2 GIRMS	Device	Two systems (ABCA-C and ABCA-D) with run order randomized	ABCA2 GIRMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alex Ryder, MD	Cairn Diagnostics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairn Diagnostics		Brentwood	Tennessee	37027	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 14, 2020	Oct 22, 2020	Prot_SAP_000.pdf

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 10, 2024			Nov 4, 2024	5

Condition Browse Module

MeSH Terms

ID	Term
D018589	Gastroparesis

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis

Browse Leaves

Not provided

Browse Branches

Not provided