GEBT Telehealth Administration Usability Study

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684992
• Other study ID #: PRO-CD-046
• Status: Completed
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: July 2021
• Source: Cairn Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• GEBT Telehealth Administration Usability
Establish the usability of a telehealth platform for the administration of GEBT

Locations

Country	Name	City	State
United States	Cairn Diagnostics	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cairn Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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