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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Oral Cancer
• Intervention / Treatment: Device: Nasopharyngoscope

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Walter Lee, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mouth Neoplasms
• Other Study ID Numbers: Pro00102912; 1R01DE028555-01A1 (U.S. NIH Grant/Contract); Protocol Number: 22-136-E (Other Identifier: NIDCR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No