UMIN-CTR Clinical Trial

Basic information
Public title	Eye movement analysis for diagnosis of disease complaining with vertigo
Acronym	Eye movement analysis of patients with vertigo
Scientific Title	Eye movement analysis for diagnosis of disease complaining with vertigo
Scientific Title:Acronym	Eye movement analysis of patients with vertigo
Region	Japan

Condition
Condition	disease complaining with vertigo
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By analyzing the abnormal eye movement using our own eye movement analysis system quantitatively the pathology of disease complaining with vertigo is made clear.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the data of eye movement
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	We use our own eye movement analysis system.
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	1 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	outpatients who have medical examinations at our hospital
Key exclusion criteria	patients who do not approve this research
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Imai
Organization	Osaka University Graduate School of Medicine
Division name	Department of Otorhinolaryngology - Head and Neck Surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL	+81-6-6879-3951
Email	timai@ent.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Imai
Organization	Osaka University Graduate School of Medicine
Division name	Department of Otorhinolaryngology - Head and Neck Surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL	06-6879-3951
Homepage URL	http://www.med.osaka-u.ac.jp/pub/ent/
Email	timai@ent.med.osaka-u.ac.jp

Sponsor
Institute	Department of Otorhinolaryngology - Head and Neck Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Hospital
Address	2-15 Yamadaoka, Suita-shi, Osaka
Tel	06-6879-5111
Email	rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	10091
Org. issuing International ID_1	Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪大学医学部附属病院、大阪労災病院

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 03 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	2015 Year 12 Month 03 Day
Date of IRB	2015 Year 12 Month 03 Day
Anticipated trial start date	2015 Year 12 Month 03 Day
Last follow-up date	2022 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 12 Month 03 Day
Last modified on	2020 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023153