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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DE028555-01A1 | U.S. NIH Grant/Contract | View source | |
| Protocol Number: 22-136-E | Other Identifier | NIDCR |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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This study aims to develop and evaluate a low-cost, portable, flexible nasopharyngeal scope (FNS) used to assess head and neck cancers (HNC) in low resource settings. The FNS will be compared to an endoscope that is used as standard of care (SOC) in terms of ease of use, image quality, and perceived pain. The ultimate goal is to compare the ease of use between the FNS to what is used in SOC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients evaluated using flexible nasopharyngoscope prototype device | Active Comparator |
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| Patients evaluated using standard of care nasopharyngoscope | No Intervention | ||
| Providers using flexible nasopharyngoscope prototype device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngoscope | Device | Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy. | up to 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the SOC scope at each value. | Day 1 |
| Image Quality of the Flexible Scope as Measured on a 5-point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Lee, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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The providers who conducted the exams (n = 9) were not considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract | Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about your experience with the investigational scope device compared to the routine scope exam. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exam With Standard Nasopharyngoscope |
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| Exam With Study Nasopharyngoscope |
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Participants who completed the study are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract | Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about their experience with the investigational scope device compared to the routine scope exam. |
| 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 |
| 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 | Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy. | Only applicable to the providers who conducted the exams. | Posted | Count of Units | Participant exams | up to 15 minutes | Participant exams | Participant exams |
|
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1 day
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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 | SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract | Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about their experience with the investigational scope device compared to the routine scope exam. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walter T. Lee, MD, MHS | Duke University | 919-613-6407 | walter.lee@duke.edu |
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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 13, 2023 | Aug 21, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2023 | Oct 27, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the flexible scope at each value. |
| Day 1 |
| Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope | Day 1 |
| Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope | Comparison made using a 3 point scale where 1=much more, 2=about the same, and 3=much less. | Day 1 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Participant exams |
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| Secondary | Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the SOC scope at each value. | Only applicable to the providers who conducted the exams. | Posted | Count of Units | Participant exams | Day 1 | Participant exams | Participant exams |
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| Secondary | Image Quality of the Flexible Scope as Measured on a 5-point Scale | Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the flexible scope at each value. | Only applicable to the providers who conducted the exams. | Posted | Count of Units | Participant exams | Day 1 | Participant exams | Participant exams |
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| Secondary | Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope | Participants who completed the study. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope | Comparison made using a 3 point scale where 1=much more, 2=about the same, and 3=much less. | Participants who completed the study. | Posted | Count of Participants | Participants | Day 1 |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
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| 4=Very Good |
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| 5=Excellent |
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| 4=Very Good |
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| 5=Excellent |
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