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.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Device: GEBT Telehealth Administration Usability

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Cairn Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GEBT Telehealth Administration Usability; Establish the usability of a telehealth platform for the administration of GEBT	Device: GEBT Telehealth Administration Usability; Establish the usability of a telehealth platform for the administration of GEBT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairn Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): March 10, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Telehealth; Gastroenterology; Gastric emptying breath test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: PRO-CD-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes