UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of findings of inner ear enhanced MRI in patients with Meniere disease
Acronym	Enhanced MRI in Meniere patients
Scientific Title	Investigation of findings of inner ear enhanced MRI in patients with Meniere disease
Scientific Title:Acronym	Enhanced MRI in Meniere patients
Region	Japan

Condition
Condition	Meniere disease
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between the period of Meniere disease and findings of inner ear enhanced MRI.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between the period of Meniere disease and findings of inner ear enhanced MRI
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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Inner ear enhanced MRI
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The case with Meniere disease who are agreed with this study.
Key exclusion criteria	Patients with allergy of gadolinium. Patients with failure of kidney. patients with asthma.
Target sample size	100

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	Suita-shi
TEL	06-6879-3951
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	Otorhinolaryngology - Head and Neck Surgery
Zip code	565-0871
Address	2-2 Yamadaoka
TEL	06-6879-3951
Homepage URL
Email	timai@ent.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Graduate School of Medicine
Address	2-2 Yamadaoka, Suita-shi
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-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

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 25 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	2019 Year 09 Month 01 Day
Date of IRB	2019 Year 09 Month 01 Day
Anticipated trial start date	2019 Year 09 Month 10 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 11 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043304