Tokyo, Sept. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059164) titled 'Functional Evaluation Study of a Laryngeal Elevation Distance Measurement Device Using Piezoelectric Braided Cord and Photoelastic Fiber' on Sept. 22.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - dysphagia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the reliability of the data obtained from this device
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - This is a validation study of a healthcare device, aiming to confirm the correlation between laryngeal movement distance measured by videofluoroscopic swallowing study (VFSS) and that measured by the device
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - over 18 years old
Key exclusion criteria - Individuals with a markedly short neck that prevents device placement
Dementia
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 22 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067674
Disclaimer: Curated by HT Syndication.
