Head and Neck Cancer, Oral Cancer
Conditions
Brief summary
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.
Interventions
DEVICENasopharyngoscope
Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female, aged 18 or older * Patients who clinical meet clinical criteria for SOC scope examination of the upper aerodigestive tract. This includes signs and symptoms such as dysphagia, nasal obstruction, neck mass, throat pain, and hoarseness.
Exclusion criteria
* Withdrawal of consent during the study duration * Subjects who have complications from the SOC exam * Anyone unable to under the SOC exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | up to 15 minutes | Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | Day 1 | 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. |
| Image Quality of the Flexible Scope as Measured on a 5-point Scale | Day 1 | 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. |
| 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 | Day 1 | Comparison made using a 3 point scale where 1=much more, 2=about the same, and 3=much less. |
Countries
United States
Participant flow
Pre-assignment details
The providers who conducted the exams (n = 9) were not considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Exam With Standard Nasopharyngoscope | Study device not available | 2 |
| Exam With Standard Nasopharyngoscope | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
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.
Time frame: up to 15 minutes
Population: Only applicable to the providers who conducted the exams.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | 1=Very hard | 0 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | 2=Harder | 9 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | 3=Same | 33 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | 4=Easier | 6 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use | 5=Very Easy | 2 Participant exams |
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.
Time frame: Day 1
Population: Only applicable to the providers who conducted the exams.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Flexible Scope as Measured on a 5-point Scale | 1=Poor | 0 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Flexible Scope as Measured on a 5-point Scale | 2=Fair | 0 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Flexible Scope as Measured on a 5-point Scale | 3=Good | 2 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Flexible Scope as Measured on a 5-point Scale | 4=Very Good | 13 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Flexible Scope as Measured on a 5-point Scale | 5=Excellent | 35 Participant exams |
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.
Time frame: Day 1
Population: Only applicable to the providers who conducted the exams.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | 1=Poor | 0 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | 2=Fair | 0 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | 3=Good | 0 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | 4=Very Good | 14 Participant exams |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale | 5=Excellent | 36 Participant exams |
Secondary
Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope
Time frame: Day 1
Population: Participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope | 0 Participants |
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.
Time frame: Day 1
Population: Participants who completed the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope | 1=much more | 6 Participants |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope | 2=about the same | 29 Participants |
| Providers Using Flexible Nasopharyngoscope Prototype Device | Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope | 3=much less | 15 Participants |
Comparison: Flexible scope compared with the SOC scopep-value: 0.04Fisher Exact