Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase
NCT ID: NCT04905134
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2023-07-31
2023-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Patients evaluated using flexible nasopharyngoscope prototype device
Nasopharyngoscope
Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
Patients evaluated using standard of care nasopharyngoscope
No interventions assigned to this group
Providers using flexible nasopharyngoscope prototype device
Nasopharyngoscope
Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
Interventions
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Nasopharyngoscope
Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects who have complications from the SOC exam
* Anyone unable to under the SOC exam
18 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Walter Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Protocol Number: 22-136-E
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00102912
Identifier Type: -
Identifier Source: org_study_id
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