Status:
COMPLETED
GEBT Telehealth Administration Usability Study
Lead Sponsor:
Cairn Diagnostics
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04684992
Start Date
December 11 2020
End Date
March 10 2021
Last Update
August 24 2021
Active Locations (1)
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1
Cairn Diagnostics
Brentwood, Tennessee, United States, 37027