Clinical trial NCT04684992: GEBT Telehealth Administration Usability Study
Official title: Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroenterology
Gastric emptying breath test
Telehealth
Lead sponsor: Cairn Diagnostics
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.

Detailed description: This study is intended to demonstrate that the 13C-Spirulina Gastric Emptying Breath Test (GEBT) can be successfully administered via a telehealth platform. Telehealth administration of GEBT is where a trained Cairn employee uses a video link to remotely supervise the completion of the test request form, collection of breath samples, cooking and consumption of the test meal and return of breath samples by the patient to Cairn.

Eligibility criteria: Inclusion Criteria:

* Males and females, greater than or equal to 18 years of age at the time of signing the consent form, from healthy and intended use population (i.e. symptomatic for gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration.
* Ability to eat test meal and provide breath samples
* Access to a microwave oven at home
* Internet connection and telehealth accessible device (smart phone/tablet/computer with visual and voice capability) at home
* Environment to sit comfortably and quietly at home

Exclusion Criteria:

* History or physical exam suggestive of systemic disease such as pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption syndrome
* History of abdominal surgery except appendectomy
* Females on hormone replacement therapy other than birth control medications
* Receipt of any investigational drug within 4 weeks of the study
* Pregnancy
* Intolerance or allergy to any component of GEBT meal
* History of neurological or psychiatric disorders

Primary outcomes:
measure: Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
timeFrame: 1 day
measure: Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
timeFrame: up to 1 week
measure: Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
timeFrame: 2-4 days
measure: Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
timeFrame: up to 1 week
measure: Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional
timeFrame: up to 1 week
measure: Ability to Successfully Ship Kits/Breath Samples to/From Home
timeFrame: Up to 3 weeks
measure: Ability of a Telehealth Platform to Function Correctly
timeFrame: 1 day
measure: Ability of a Telehealth Platform to Function Correctly
timeFrame: Up to 3 weeks
measure: Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: Cairn Diagnostics
state: Tennessee
Study officials:
affiliation: Cairn Diagnostics
name: Alex Ryder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: