GEBT Telehealth Administration Usability Study

Not Applicable

Completed

Conditions: Gastroparesis

Interventions: Device: GEBT Telehealth Administration Usability

Registration Number: NCT04684992

Lead Sponsor: Cairn Diagnostics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GEBT Telehealth Administration Usability	GEBT Telehealth Administration Usability	Establish the usability of a telehealth platform for the administration of GEBT

Primary Outcome Measures

Name	Time	Method
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional	up to 1 week	Ability to collect GEBT breath samples will be assessed by examination of GEBT results for participants (ensuring adequate CO2 in each sample/delta values follow expected pattern if collected in correct order).
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions	up to 1 week	Ability to complete the GEBT test request form will be assessed by a patient questionnaire.
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions	up to 1 week	Ability to prepare GEBT will be assessed by a patient questionnaire.
Ability to Successfully Ship Kits/Breath Samples to/From Home	Up to 3 weeks	Ability to ship GEBT kits/breath samples to/from home will be assessed by surveying patients regarding shipping and by recording the dates that kits were shipped and received
Ability of a Telehealth Platform to Function Correctly	Up to 3 weeks	Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire
Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility	Up to 3 weeks	Any adverse events reported will be reviewed by Cairn's medical director to assess that there is no more than expected frequency of adverse events during administration of GEBT by a telehealth professional than would be expected during administration of GEBT in a clinician's facility. This will be performed by comparing the current rate of events in a physician's office versus under the supervision of a telehealth professional as identified through the risk analyses performed for GEBT administration.