UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045151 |
|---|---|
| Receipt number | R000051567 |
| Scientific Title | Inventing new type of denture shaped alternative vocalization |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/08/13 19:18:05 |
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Basic information
Public title
Inventing new type of denture shaped alternative vocalization
Acronym
Inventing new type of denture shaped alternative vocalization
Scientific Title
Inventing new type of denture shaped alternative vocalization
Scientific Title:Acronym
Inventing new type of denture shaped alternative vocalization
Region
| Japan |
Condition
Condition
laryngectomy
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research for efficacy of new electrolarynx
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intelligibility
Key secondary outcomes
QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
We will give you a new artificial larynx and an existing electric artificial larynx and measure how much you can speak compared to the existing alternative vocalization method.
For the diseased group, use the new artificial larynx as it is and observe the improvement of pronunciation and the change of QOL.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who can speak now or who have acquired vocalizations in the past but have lost their voices
Key exclusion criteria
Persons with a history of organic diseases of the tongue and buccal mucosa due to oral cancer, etc.
Persons who have difficulty in following instructions due to dementia, etc.
Those who are at risk of tooth detachment due to impression taking due to swaying teeth, etc.
Those who have difficulty in taking an impression in the oral cavity due to trismus, etc.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
113-0034
Address
1-5-45 Yushima Bunkyo-ward Tokyo
TEL
0358035562
yamadent68@gmail.com
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
113-0034
Address
1-5-45 Yushima Bunkyo-ward Tokyo
TEL
0358035562
Homepage URL
yamadent68@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ward Tokyo
Tel
0358034300
d-hyoka.adm@tmd.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
東京医科歯科大学歯学部附属病院（東京都）、大阪赤十字病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051567
