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Completed

NCT Number: NCT04684992

GEBT Telehealth Administration Usability Study

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

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairn Diagnostics

Brentwood, Tennessee, 37027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GEBT Telehealth Administration Usability

Device

Establish the usability of a telehealth platform for the administration of GEBT

Primary outcomes

  1. Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions

    Time frame: 1 day

    Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.

  2. Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions

    Time frame: up to 1 week

    Ability to prepare GEBT will be assessed by a patient questionnaire.

  3. Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions

    Time frame: 2-4 days

    Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples.

  4. Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions

    Time frame: up to 1 week

    Ability to complete the GEBT test request form will be assessed by a patient questionnaire.

  5. Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional

    Time frame: up to 1 week

    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).

  6. Ability to Successfully Ship Kits/Breath Samples to/From Home

    Time frame: Up to 3 weeks

    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

  7. Ability of a Telehealth Platform to Function Correctly

    Time frame: 1 day

    Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire

  8. Ability of a Telehealth Platform to Function Correctly

    Time frame: Up to 3 weeks

    Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire

  9. Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility

    Time frame: Up to 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairn Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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