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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

Tracking Information
First Submitted Date  ICMJE May 24, 2021
First Posted Date  ICMJE May 27, 2021
Last Update Posted Date January 25, 2023
Estimated Study Start Date  ICMJE May 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2021)
  • Rate of image quality of rigid scope [ Time Frame: Day 1 ]
    Measured using 5 point scale, with 1 being poor and 5 being excellent
  • Rate of image quality of flexible scope [ Time Frame: Day 1 ]
    Measured using 5 point scale, with 1 being poor and 5 being excellent
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Cancer
  • Oral Cancer
Intervention  ICMJE Device: Nasopharyngoscope
Low-cost, flexible scope prototype will compared to rigid scope used as standard of care.
Study Arms  ICMJE
  • Active Comparator: Patients evaluated using flexible nasopharyngoscope prototype
    Intervention: Device: Nasopharyngoscope
  • No Intervention: Patients evaluated using rigid nasopharyngoscope per SOC
  • Active Comparator: Providers using flexible nasopharyngoscope prototype
    Intervention: Device: Nasopharyngoscope
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Walter Lee, MD 919-681-8449 walter.lee@duke.edu
Contact: Amy Walker 919-684-1732 amy.walker1@duke.edu
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04905134
Other Study ID Numbers  ICMJE Pro00102912
1R01DE028555-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Walter Lee, MD Duke Health
PRS Account Duke University
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP