Back to resultsGEBT Telehealth Administration Usability Study
Primary Purpose
Gastroparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GEBT Telehealth Administration Usability
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroparesis focused on measuring Gastroenterology, Gastric emptying breath test, Telehealth
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
Sites / Locations
- Cairn Diagnostics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GEBT Telehealth Administration Usability
Arm Description
Establish the usability of a telehealth platform for the administration of GEBT
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04684992
Brief Title
GEBT Telehealth Administration Usability Study
Official Title
Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cairn Diagnostics
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroenterology, Gastric emptying breath test, Telehealth
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GEBT Telehealth Administration Usability
Arm Type
Experimental
Arm Description
Establish the usability of a telehealth platform for the administration of GEBT
Intervention Type
Device
Intervention Name(s)
GEBT Telehealth Administration Usability
Intervention Description
Establish the usability of a telehealth platform for the administration of GEBT
Primary Outcome Measure Information:
Title
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
Description
Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.
Time Frame
1 day
Title
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
Description
Ability to prepare GEBT will be assessed by a patient questionnaire.
Time Frame
up to 1 week
Title
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
Description
Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples.
Time Frame
2-4 days
Title
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
Description
Ability to complete the GEBT test request form will be assessed by a patient questionnaire.
Time Frame
up to 1 week
Title
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional
Description
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).
Time Frame
up to 1 week
Title
Ability to Successfully Ship Kits/Breath Samples to/From Home
Description
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
Time Frame
Up to 3 weeks
Title
Ability of a Telehealth Platform to Function Correctly
Description
Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire
Time Frame
1 day
Title
Ability of a Telehealth Platform to Function Correctly
Description
Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire
Time Frame
Up to 3 weeks
Title
Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility
Description
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.
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Ryder, MD, PhD
Organizational Affiliation
Cairn Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairn Diagnostics
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GEBT Telehealth Administration Usability Study
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