UMIN-CTR Clinical Trial

Basic information
Public title	Study of usefulness of pocket sized ultrasonography for evaluation of swallowing function
Acronym	Usefulness of pocket sized ultrasonography in swallowing evaluation
Scientific Title	Study of usefulness of pocket sized ultrasonography for evaluation of swallowing function
Scientific Title:Acronym	Usefulness of pocket sized ultrasonography in swallowing evaluation
Region	Japan

Condition
Condition	Healthy condition Target population: individuals with Dysphagia
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of pocket sized ultrasonography in examination of swallowing function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pocket sized versus portable Ultrasnography in imaging of thickness, cross-sectional area and fat mass of masseter muscles, tongue and suprahyoid muscles.
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	One day, about an hour 3times per an examination (1) Pocket sized ultrasonography SONIMAGEP3 (KONICAMINOLTA Japnan, Inc) (Medical Device Certification Number: 225ABBZX00129000) (2) Portable ultrasonography SonoSite M-Turbo (FUJIFILM, Corp) (Medical Device Certification Number: 219ADBZI00197000)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy volunteer with occlusal support
Key exclusion criteria	Individuals with systemic disease, dysphagia, respiratory disease, otorhinolaryngologic dease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shunsuke Middle name Last name Minakuchi
Organization	Tokyo Medical and Dental University
Division name	Division of Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL	03-5803-5559
Email	haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Tanaka
Organization	Nihon university school of Dentistry at Matsudo
Division name	Division of Special Needs Dentistry
Zip code	271-8587
Address	2-87-1, sakaecho-nishi, Matsudo, Chiba, 271-8587, Japan
TEL	047-360-9443
Homepage URL
Email	tanaka.yoko@nihon-u.ac.jp

Sponsor
Institute	Tokyo medical and dental University
Institute
Department

Funding Source
Organization	Tokyo medical and dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Nihon University School of Dentistry at Matsudo
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon Universtiy School of Dentistry at Matsudo
Address	2-870-1, sakaecho-nichi, matsudo, Chiba
Tel	047-360-9443
Email	tanaka.yoko@nihon-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	東京医科歯科大学

Other administrative information
Date of disclosure of the study information	2018 Year 03 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	Suspended
Date of protocol fixation	2018 Year 01 Month 20 Day
Date of IRB	2008 Year 07 Month 25 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2019 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 14 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035173