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

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Tongue neoplasm
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Brief Title

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

Official Title

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

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 the rigid endoscope that is used as standard of care in terms of ease of use,
      image quality, and perceived pain. The ultimate goal is to implement widespread training and
      use of the optimized FNS to improve care capacity by local heath providers in Vietnam through
      timely diagnosis, treatment and/or appropriate specialized referral for HNC patients.

Study Type

Interventional

Primary Outcome

Number of providers who who reported the FNS is easy to use

Secondary Outcome

 Rate of image quality of rigid scope

Condition

Head and Neck Cancer

Intervention

Nasopharyngoscope

Study Arms / Comparison Groups

 Patients evaluated using flexible nasopharyngoscope prototype
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

150

Start Date

May 2023

Completion Date

August 2023

Primary Completion Date

August 2023

Eligibility Criteria

        Inclusion Criteria:

          -  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 rigid 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:

          -  Subjects who have complications from the SOC rigid exam

          -  Anything that would place the individual at increased risk or preclude the
             individual's full compliance with or completion of the study.

          -  Withdrawal of consent during the study duration

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Walter Lee, MD, 919-681-8449, [email protected]

Location Countries

Vietnam

Location Countries

Vietnam

Administrative Informations

NCT ID

NCT04905134

Organization ID

Pro00102912

Secondary IDs

1R01DE028555-01A1

Responsible Party

Sponsor

Study Sponsor

Duke University

Collaborators

 National Institute of Dental and Craniofacial Research (NIDCR)

Study Sponsor

Walter Lee, MD, Principal Investigator, Duke Health

Verification Date

January 2023