UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000030803
Receipt No. R000035173
Scientific Title Study of usefulness of pocket sized ultrasonography for evaluation of swallowing function
Date of disclosure of the study information 2018/03/01
Last modified on 2019/07/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000035173

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.