GEBT Telehealth Administration Usability Study

Cairn Diagnostics

Status

Completed

Conditions

Gastroparesis

Treatments

Device: GEBT Telehealth Administration Usability

Study type

Interventional

Funder types

Industry

Identifiers

NCT04684992

PRO-CD-046

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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