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ABCA2 GIRMS Analytical Validation Clinical Performance Study

NCT ID: NCT04607304

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-07-27

Brief Summary

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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

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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

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Gastroparesis

Keywords

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Gastroenterology Gastric Emptying Breath Test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ABCA2 GIRMS

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

Group Type EXPERIMENTAL

ABCA2 GIRMS

Intervention Type DEVICE

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

Interventions

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ABCA2 GIRMS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairn Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Ryder, MD

Role: PRINCIPAL_INVESTIGATOR

Cairn Diagnostics

Locations

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Cairn Diagnostics

Brentwood, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PRO-CD-044

Identifier Type: -

Identifier Source: org_study_id