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The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEBT Telehealth Administration Usability | Experimental | Establish the usability of a telehealth platform for the administration of GEBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEBT Telehealth Administration Usability | Device | Establish the usability of a telehealth platform for the administration of GEBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Ryder, MD, PhD | Cairn Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairn Diagnostics | Brentwood | Tennessee | 37027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GEBT Telehealth Administration Usability | Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GEBT Telehealth Administration Usability | Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 1 day |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GEBT Telehealth Administration Usability | Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excessive burping and nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientist and Compliance Officer | Cairn Diagnostics | 615-376-5464 | cwilliams@cairndx.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2020 | Dec 21, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | 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. | Study participants assessed on a patient questionnaire whether the meal preparation instructions were clear and easy to follow. | Posted | Number | participants | up to 1 week |
|
|
|
| Primary | 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. | Posted | Number | participants | 2-4 days |
|
|
|
| Primary | 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. | Participants assessed easy of completing the GEBT test request form. | Posted | Number | participants | up to 1 week |
|
|
|
| Primary | 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). | Posted | Number | participants | up to 1 week |
|
|
|
| Primary | 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 | Posted | Number | participants | Up to 3 weeks |
|
|
|
| Primary | 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 | Posted | Number | participants | 1 day |
|
|
|
| Primary | 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 | Participants assessed reliability and ease of use of telehealth platform. | Posted | Number | participants | Up to 3 weeks |
|
|
|
| Primary | 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. | There were no adverse events associated with telehealth administration via the telehealth procedure (e.g., burns during microwave cooking or injuries from breath collection apparatus). | Posted | Number | AEs associated with telehealth | Up to 3 weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 3 |
| 34 |
| Severe bloating and excessive gas | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting and dehydration | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Meal start/end times recorded correctly |
|
| Post-meal sample times recorded |
|
| Title | Measurements |
|---|---|
|
| Adequate %CO2 (>1%) |
|
| Samples follow excretion curve shape |
|
| Breath samples easy to collect |
|
| Title | Measurements |
|---|
|