Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase

Study Overview
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Brief Summary
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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.

Official Title
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Partnership to Establish a Practice Based Network to Assess for Head and Neck Cancers Using a Low-Cost Portable Flexible Nasopharyngoscope - Optimization Phase

Conditions
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Head and Neck Cancer, Oral Cancer

Intervention / Treatment
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* Device: Nasopharyngoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients evaluated using flexible nasopharyngoscope prototype device<br> | Device: Nasopharyngoscope<br>* Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.<br>|
| No Intervention: Patients evaluated using standard of care nasopharyngoscope<br> | |
| Active Comparator: Providers using flexible nasopharyngoscope prototype device<br> | Device: Nasopharyngoscope<br>* Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of providers who who reported the FNS 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of image quality of rigid scope | Measured using 5 point scale, with 1 being poor and 5 being excellent | Day 1 | 
| Rate of image quality of flexible scope | Measured using 5 point scale, with 1 being poor and 5 being excellent | Day 1 | 
| Number of patients who reported perceived pain following use of the flexible scope | Comparison using a 3 point scale, with 1 being much more and 3 being much less | Day 1 | 
| Number of patients who experienced an adverse event following the use of the flexible scope | measured by a provider questionnaire following completion of flexible scope exam | Day 1 |