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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04905134
Recruitment Status : Not yet recruiting
First Posted : May 27, 2021
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Cancer Device: Nasopharyngoscope Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Partnership to Establish a Practice Based Network to Assess for Head and Neck Cancers Using a Low-Cost Portable Flexible Nasopharyngoscope
Estimated Study Start Date : May 2023
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Patients evaluated using flexible nasopharyngoscope prototype Device: Nasopharyngoscope
Low-cost, flexible scope prototype will compared to rigid scope used as standard of care.
No Intervention: Patients evaluated using rigid nasopharyngoscope per SOC
Active Comparator: Providers using flexible nasopharyngoscope prototype Device: Nasopharyngoscope
Low-cost, flexible scope prototype will compared to rigid scope used as standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Number of providers who who reported the FNS is easy to use [ Time Frame: up to 15 minutes ]
    Measured using a 5 point scale, with 1 = very easy, 2=easier, 3 = same, 4= harder and 5 = very hard


Secondary Outcome Measures :
  1. Rate of image quality of rigid scope [ Time Frame: Day 1 ]
    Measured using 5 point scale, with 1 being poor and 5 being excellent

  2. Rate of image quality of flexible scope [ Time Frame: Day 1 ]
    Measured using 5 point scale, with 1 being poor and 5 being excellent

  3. Number of patients who reported perceived pain following use of the flexible scope [ Time Frame: Day 1 ]
    Comparison using a 3 point scale, with 1 being much less and 3 being much more

  4. Number of patients who experienced an adverse event following the use of the flexible scope [ Time Frame: Day 1 ]
    measured by a provider questionnaire following completion of flexible scope exam


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905134


Contacts
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Contact: Walter Lee, MD 919-681-8449 walter.lee@duke.edu
Contact: Amy Walker 919-684-1732 amy.walker1@duke.edu

Locations
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Vietnam
National ENT Hospital
Hanoi, Vietnam
Contact: Trung Nguyen, MD    84 24 3852 3798    trungent23@yahoo.com   
Principal Investigator: Trung Nguyen, MD         
Sponsors and Collaborators
Duke University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Walter Lee, MD Duke Health
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04905134    
Other Study ID Numbers: Pro00102912
1R01DE028555-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases