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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Oral Cancer
• Interventions: Device: Nasopharyngoscope

• Registration Number: NCT04905134
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2023-07-31
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

• Withdrawal of consent during the study duration
• Subjects who have complications from the SOC exam
• Anyone unable to under the SOC exam

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients evaluated using flexible nasopharyngoscope prototype device	Nasopharyngoscope	-
Providers using flexible nasopharyngoscope prototype device	Nasopharyngoscope	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States