UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059164 |
|---|---|
| Receipt number | R000067674 |
| Scientific Title | Functional Evaluation Study of a Laryngeal Elevation Distance Measurement Device Using Piezoelectric Braided Cord and Photoelastic Fiber |
| Date of disclosure of the study information | 2025/09/22 |
| Last modified on | 2025/09/22 22:16:08 |
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Basic information
Public title
Functional Evaluation Study of a Laryngeal Elevation Distance Measurement Device Using Piezoelectric Braided Cord and Photoelastic Fiber
Acronym
Functional Evaluation Study of a Laryngeal Elevation Distance Measurement Device
Scientific Title
Functional Evaluation Study of a Laryngeal Elevation Distance Measurement Device Using Piezoelectric Braided Cord and Photoelastic Fiber
Scientific Title:Acronym
Functional Evaluation Study of a Laryngeal Elevation Distance Measurement Device
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the reliability of the data obtained from this device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Laryngeal elevation distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suehiro |
Organization
Kyoto University
Division name
ENT
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513346
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suehiro |
Organization
Kyoto University
Division name
ENT
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513346
Homepage URL
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
Tel
0757513346
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067674
