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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905134
• Other study ID #: Pro00102912
• Secondary ID: 1R01DE028555-01A
• Status: Completed
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: September 22, 2023

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mouth Neoplasms
• Oral Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of providers who who reported the FNS 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	Rate of image quality of rigid scope	Measured using 5 point scale, with 1 being poor and 5 being excellent	Day 1
Secondary	Rate of image quality of flexible scope	Measured using 5 point scale, with 1 being poor and 5 being excellent	Day 1
Secondary	Number of patients who reported perceived pain following use of the flexible scope	Comparison using a 3 point scale, with 1 being much more and 3 being much less	Day 1
Secondary	Number of patients who experienced an adverse event following the use of the flexible scope	measured by a provider questionnaire following completion of flexible scope exam	Day 1