GEBT Telehealth Administration Usability Study

Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study

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

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.

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