GEBT Telehealth Administration Usability Study

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

Detailed Description
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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.

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

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: GEBT Telehealth Administration Usability


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEBT Telehealth Administration Usability<br>Establish the usability of a telehealth platform for the administration of GEBT | Device: GEBT Telehealth Administration Usability<br>* Establish the usability of a telehealth platform for the administration of GEBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions | Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient. | 1 day | 
| Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions | Ability to prepare GEBT will be assessed by a patient questionnaire. | up to 1 week | 
| Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions | Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples. | 2-4 days | 
| Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions | Ability to complete the GEBT test request form will be assessed by a patient questionnaire. | up to 1 week | 
| Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | 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). | up to 1 week | 
| Ability to Successfully Ship Kits/Breath Samples to/From Home | 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 | Up to 3 weeks | 
| Ability of a Telehealth Platform to Function Correctly | Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire | 1 day | 
| Ability of a Telehealth Platform to Function Correctly | Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire | Up to 3 weeks | 
| Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility | 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. | Up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenterology, Gastric emptying breath test, Telehealth