N/A
N=53
Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase
Head and Neck Cancer · Oral Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04905134 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use — 0; 9; 33; 6 Participant exams
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasopharyngoscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use |
0; 9; 33; 6; 2 | — |
| SECONDARY Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale |
0; 0; 0; 14; 36 | — |
| SECONDARY Image Quality of the Flexible Scope as Measured on a 5-point Scale |
0; 0; 2; 13; 35 | — |
| SECONDARY Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope |
— | — |
| 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 |
6; 29; 15 | 0.04 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04905134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.