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| Name | Class |
|---|---|
| Medex15 | INDUSTRY |
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This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.
The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).
After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.
Around 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate.
The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Virtual patient cases with GERD and similar BE risk factors as the cases in intervention but without an EsoGuard result and in a different order. | |
| Intervention | Active Comparator | Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm with an EsoGuard result. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EsoGuard result | Device | Education slide-set EsoGuard and patient cases including EsoGuard result |
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| Measure | Description | Time Frame |
|---|---|---|
| The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral | The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases | The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria T Lee, MD | Lucid Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucid Diagnostics | New York | New York | 10017 | United States |
A total of 90 providers completed the control round questionnaire with 6 control cases (total of 540 control cases) and a total of 87 completed the intervention round questionnaire with 6 cases (total of 522 intervention cases).
97 physicians (participant providers) signed an ICF.
| ID | Title | Description |
|---|---|---|
| FG000 | Participating Physicians | Each participating physician completed 2 times a questionnaire with 6 virtual patient cases per provider with GERD, BE risk factors and without an EsoGuard result and with an EsoGuard result. With 90 participants the total in the control group is 540 control cases, and 87 participants completed the second questionnaire leading to 522 intervention cases. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2023 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participating Physicians | Participating physicians could be primary care physicians or specialists. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Data not collected | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Physician type | Primary Care | Count of Participants | Participants | No |
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| 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 | The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral | The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases. | A total of 540 control cases were reviewed by 90 providers, and a total of 522 intervention cases were reviewed by 87 providers. | Posted | Number | Cases | 1 month | Cases | Cases |
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| Secondary | The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases | The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases. | A total of 90 EsoGuard + control cases were reviewed by 90 providers, and a total of 87 EsoGuard + intervention cases were reviewed by 87 providers. | Posted | Number | Cases | 1 month | Cases | Cases |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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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 | Participants | Physician providers who completed online questionnaires | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria T. Lee, MD CMO, SVM Clinical Affairs | PAVmed Inc., Lucid Diagnostics Inc. | 425.218.6535 | VTL@PAVmed.com |
| Oct 1, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| >=65 years |
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| Specialist |
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| Cases |
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