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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 June 2021 |
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Main ID: |
NCT04905134 |
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Date of registration:
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24/05/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings
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Scientific title:
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Partnership to Establish a Practice Based Network to Assess for Head and Neck Cancers Using a Low-Cost Portable Flexible Nasopharyngoscope |
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Date of first enrolment:
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September 2021 |
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Target sample size:
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150 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04905134 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Trung Nguyen, MD |
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Address:
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Telephone:
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84 24 3852 3798 |
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Email:
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trungent23@yahoo.com |
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Affiliation:
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Name:
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Walter Lee, MD |
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Address:
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Telephone:
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919-681-8449 |
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Email:
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walter.lee@duke.edu |
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Affiliation:
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Name:
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Walter Lee, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke Health |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Head and Neck Cancer
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Oral Cancer
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Intervention(s)
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Device: Nasopharyngoscope
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Primary Outcome(s)
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Number of providers who who reported the FNS is easy to use
[Time Frame: up to 15 minutes]
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Secondary Outcome(s)
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Number of patients who experienced an adverse event following the use of the flexible scope
[Time Frame: Day 1]
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Number of patients who reported perceived pain following use of the flexible scope
[Time Frame: Day 1]
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Rate of image quality of flexible scope
[Time Frame: Day 1]
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Rate of image quality of rigid scope
[Time Frame: Day 1]
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Secondary ID(s)
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1R01DE028555-01A1
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Pro00102912
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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