UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of swallowing evaluation method by ultrasound using a viscous air bubble liquid
Title of the study (Brief title)	Study of swallowing evaluation method by ultrasound
Region	Japan

Condition
Condition	Normal adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For the purpose of development of the swallowing function evaluation using ultrasound, to investigate the effectiveness of the liquid containing bubbles in order to clear a representation of an ultrasound image.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confirmation of the contrast effect on the ultrasound image
Key secondary outcomes	Calculation of visualization rate of swallowing Evaluation of the tongue movement Evaluation of the epiglottis movement Evaluation of the soft palate movement

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Maneuver
Interventions/Control_1	Oral ingestion of the micro bubble containing liquid
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	There is no hindrance in daily life, swallowing function is normal adult
Key exclusion criteria	Failure of oral function, those with a history or having a disease of the maxillofacial area
Target sample size	10

Research contact person
Name of lead principal investigator	Murata Naomichi
Organization	Okayama University
Division name	Special Needs Dentistry
Address	2-5-1 Shikata-cho Kita-ku Okayama city
TEL	086-235-6823
Email	murata-n@md.okayama-u.ac.jp

Public contact
Name of contact person	Murata Naomichi
Organization	Okayama University Hospital
Division name	Center for the Special Needs Dentistry
Address	2-5-1 Shikata-cho Kita-ku Okayama city
TEL	086-235-6823
Homepage URL
Email	murata-n@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 20 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024477