N/A
Completed N=36
GEBT Telehealth Administration Usability Study
Source: ClinicalTrials.gov NCT04684992 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions — 34; 34; 34; 34 participants
Summary
The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions |
34 | — |
| PRIMARY Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions |
34 | — |
| PRIMARY Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions |
34 | — |
| PRIMARY Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions |
34 | — |
| PRIMARY Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional |
33; 33; 34; 34; 34; 34 | — |
| PRIMARY Ability to Successfully Ship Kits/Breath Samples to/From Home |
34; 34 | — |
| PRIMARY Ability of a Telehealth Platform to Function Correctly |
32 | — |
| PRIMARY Ability of a Telehealth Platform to Function Correctly |
32 | — |
| PRIMARY Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04684992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.