GEBT Telehealth Administration Usability Study

NCT04684992 | Completed Results FDA Device

• 1 other identifier: PRO-CD-046
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroparesis

Keywords

Gastroenterology; Gastric emptying breath test; Telehealth

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

GEBT Telehealth Administration Usability

EXPERIMENTAL

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

Device: GEBT Telehealth Administration Usability

Interventions

GEBT Telehealth Administration Usability DEVICE

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

GEBT Telehealth Administration Usability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairn Diagnostics: lead

Study Sites (1)

Cairn Diagnostics

Brentwood, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Scientist and Compliance Officer
• Organization: Cairn Diagnostics

cwilliams@cairndx.com

615-376-5464

Study Officials

• Alex Ryder, MD, PhD

  Cairn Diagnostics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 28, 2020
• Study Start: December 11, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)