UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041350 |
|---|---|
| Receipt number | R000047208 |
| Scientific Title | dysphagia diagnostic method by high resolution manometry |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2025/02/10 10:48:49 |
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Basic information
Public title
dysphagia diagnostic method by high resolution manometry
Acronym
dysphagia diagnostic method by high resolution manometry
Scientific Title
dysphagia diagnostic method by high resolution manometry
Scientific Title:Acronym
dysphagia diagnostic method by high resolution manometry
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluate swallowing dynamics by high-resolution manometry in healthy subjects.
Basic objectives2
Others
Basic objectives -Others
Swallowing pressure measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
swallowing pressure
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
High resolution manometry once
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
There are no symptoms of dysphagia and no history of diseases that may cause dysphagia
Provide written informed consent signed by the subject
Key exclusion criteria
Nasal congestion
pregnancy
Lidocaine allergy
Asthma, hypertension, cardiovascular disease
Cognitive decline
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kaori |
| Middle name | |
| Last name | Tanaka |
Organization
Ehime University Hospital
Division name
otorhinolaryngology
Zip code
7910295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5366
knishiku@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | kaori |
| Middle name | |
| Last name | Tanaka |
Organization
Ehime University Hospital
Division name
otorhinolaryngology
Zip code
7910295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5366
Homepage URL
knishiku@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Dept of otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Hospital Dept of otorhinolaryngology
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5366
knishiku@m.ehime-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
| 2020 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2020 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047208
