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

NCT04905134 | Completed Results DMC

• 3 other identifiers: Pro001029121R01DE028555-01A1Protocol Number: 22-136-E
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Oral Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale

  Day 1

• Image Quality of the Flexible Scope as Measured on a 5-point Scale

  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

  Day 1

Study Arms (3)

Patients evaluated using flexible nasopharyngoscope prototype device

ACTIVE COMPARATOR

Device: Nasopharyngoscope

Patients evaluated using standard of care nasopharyngoscope

NO INTERVENTION

Providers using flexible nasopharyngoscope prototype device

ACTIVE COMPARATOR

Device: Nasopharyngoscope

Interventions

Nasopharyngoscope DEVICE

Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.

Patients evaluated using flexible nasopharyngoscope prototype device; Providers using flexible nasopharyngoscope prototype device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Walter T. Lee, MD, MHS
• Organization: Duke University

walter.lee@duke.edu

919-613-6407

Study Officials

• Walter Lee, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: July 31, 2023
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)