GEBT Telehealth Administration Usability Study

NCT ID: NCT04684992

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2021-03-10

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

GEBT Telehealth Administration Usability

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

Group Type: EXPERIMENTAL

GEBT Telehealth Administration Usability

Intervention Type: DEVICE

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

Interventions

GEBT Telehealth Administration Usability

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairn Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Ryder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairn Diagnostics

Locations

Cairn Diagnostics

Brentwood, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PRO-CD-046

Identifier Type: -

Identifier Source: org_study_id