UMIN-CTR Clinical Trial

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
Email	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
Email	yamadent68@gmail.com

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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051567