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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037322
Receipt No. R000042552
Scientific Title Research on the fabrication method of swallowing assistance device using digital impression technique
Date of disclosure of the study information 2019/10/01
Last modified on 2021/01/12

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Basic information
Public title Research on the fabrication method of swallowing assistance device using digital impression technique
Acronym Research on the fabrication method of swallowing assistance device
Scientific Title Research on the fabrication method of swallowing assistance device using digital impression technique
Scientific Title:Acronym Research on the fabrication method of swallowing assistance device
Region
Japan

Condition
Condition Dysphagia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of manufacturing method of swallowing assistant device using digital impression system and examination of usefulness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient subjective evaluation using Vas
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Manufacturing of swallowing assistance 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Dysphagia required the swallowing assistance device
Key exclusion criteria Patients who is difficult to communicate
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Haruka
Middle name
Last name Tohara
Organization Tokyo Medical and Dental University
Division name Gerodontology and oral rehabilitation
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo, Tokyo
TEL 03-5803-5562
Email yanma627@yahoo.co.jp

Public contact
Name of contact person
1st name Yamaguchi
Middle name
Last name Kohei
Organization Tokyo Medical and Dental University
Division name Gerodontology and oral rehabilitation
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo, Tokyo
TEL 03-5803-5562
Homepage URL
Email yanma627@yahoo.co.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Self funding
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 Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo, Tokyo
Tel 03-5803-5562
Email yanma627@yahoo.co.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
2019 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
2019 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2022 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
2019 Year 07 Month 10 Day
Last modified on
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042552

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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