UMIN-CTR Clinical Trial

Basic information
Public title	Development of diagnosis and treatment for vestibular diseases by equilibrium test
Acronym	Equilibrium test
Scientific Title	Development of diagnosis and treatment for vestibular diseases by equilibrium test
Scientific Title:Acronym	Equilibrium test
Region	Japan

Condition
Condition	Equilibrium disorder
Classification by specialty	Oto-rhino-laryngology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Diagnosis of equilibrium disorder by equilibrium test.
Basic objectives2	Others
Basic objectives -Others	Development of diagnosis and treatment.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnosis and treatment of equilibrium disorder.
Key secondary outcomes	Development of Development of diagnosis and treatment for equilibrium disorders.

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	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Equilibrium test
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	10 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with vertigo/dizziness.
Key exclusion criteria	Patients who did not consent with equilibrium test.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Toru Middle name Toru Last name Miwa
Organization	Kumamoto General Hospital
Division name	Otolaryngology-Head and Neck Surgery
Zip code	8668660
Address	10-10, Toricho, Yatsishiro, Japan
TEL	+81965327111
Email	miw.com1101@gmail.com

Public contact
Name of contact person	1st name Toru Middle name Last name Miwa
Organization	Kumamoto University
Division name	Otolaryngology-Head and Neck Surgery
Zip code	8600811
Address	10-10, Toricho, Yatsishiro, Japan
TEL	+81963735255
Homepage URL
Email	miw.com1101@gmail.com

Sponsor
Institute	Kumamoto General Hospital
Institute
Department

Funding Source
Organization	Kumamoto General Hospital
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kumamoto General Hospital
Address	10-10 Toricho, YatsushiroJapan,
Tel	0965327111
Email	miw.com1101@gmail.com

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	熊本総合病院

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 12 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	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2018 Year 06 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 12 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042582