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

Duke University

Status: Completed

Conditions: Oral Cancer; Head and Neck Cancer

Treatments: Device: Nasopharyngoscope

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04905134

Pro00102912

1R01DE028555-01A1 (U.S. NIH Grant/Contract)

Protocol Number: 22-136-E (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Patients evaluated using flexible nasopharyngoscope prototype device

Active Comparator group

Treatment:

Device: Nasopharyngoscope

Patients evaluated using standard of care nasopharyngoscope

No Intervention group

Providers using flexible nasopharyngoscope prototype device

Active Comparator group

Treatment:

Device: Nasopharyngoscope