GastroparesisNCT04684992
GEBT Telehealth Administration Usability Study
A study testing GEBT Telehealth Administration Usability in people with Gastroparesis, run by Cairn Diagnostics at 1 site in United States.
Trial summary
The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GEBT Telehealth Administration Usability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- GEBT Telehealth Administration Usability
- Keywords
- Gastroenterology, Gastric emptying breath test, Telehealth
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEBT Telehealth Administration UsabilityDevice
Establish the usability of a telehealth platform for the administration of GEBT
| Study group | Role | What they receive |
|---|---|---|
| GEBT Telehealth Administration Usability | Experimental | Establish the usability of a telehealth platform for the administration of GEBT Receives: Device: GEBT Telehealth Administration Usability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start11 Dec 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairn Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Ryder, MD, PhD, Principal investigator, Cairn Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684992
- Sponsor's protocol ID
- PRO-CD-046
- Status last verified
- Jul 2021
- First submitted
- 8 Dec 2020
- Last updated
- 24 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study
- ClinicalTrials.gov ID
- NCT04684992
- Acronym / sponsor ID
- PRO-CD-046
- Conditions
- Gastroparesis
- Keywords
- Gastroenterology, Gastric emptying breath test, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairn DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 24 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEBT Telehealth Administration Usability | Experimental | Device: GEBT Telehealth Administration UsabilityEstablish the usability of a telehealth platform for the administration of GEBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEBT Telehealth Administration UsabilityEstablish the usability of a telehealth platform for the administration of GEBT | Device | GEBT Telehealth Administration Usability |
Primary outcome
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.
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.
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.
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.
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).
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
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Recruiting
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Gastroparesis Nondiabetic
Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Diabetes, Gastroparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Ryder, MD, PhD principal investigator
Cairn Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEBT Telehealth Administration Usability in people with Gastroparesis, run by Cairn Diagnostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions (time frame: 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.