Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings
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ClinicalTrials.gov Identifier: NCT04905134 |
Recruitment Status :
Not yet recruiting
First Posted : May 27, 2021
Last Update Posted : January 25, 2023
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Sponsor:
Duke University
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Duke University
Tracking Information | |||||||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE | Device: Nasopharyngoscope
Low-cost, flexible scope prototype will compared to rigid scope used as standard of care.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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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 |
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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 |