UMIN-CTR Clinical Trial

Basic information
Public title	Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Acronym	Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Scientific Title	Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Scientific Title:Acronym	Treatment effect evaluation of endolymphatic hydrops by inner ear contrast-enhanced MRI
Region	Japan

Condition
Condition	Meniere's disease, Delayed endolymphatic hydrops
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Endolymphatic hydrops in patients with intractable Meniere's disease will be evaluated by inner ear contrast-enhanced MRI. Pathogenic involvement of the hydrops and treatment effects on the hydrops will be examined.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endolymphatic hydrops on the MR image
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	Prevention
Type of intervention	Medicine
Interventions/Control_1	Inner ear contrast-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	75 years-old >
Gender	Male and Female
Key inclusion criteria	# Definitive Meniere's disease or delayed endolymphatic hydrops # Intractable case with frequent vertigo attacks (atleast once a month, for 6 months or over) # No renal problem (less than 0.9mg/dl serum creatinine)
Key exclusion criteria	# Previous adverse experiences with (contrast-enhanced) MRI # Braoncheal asthma symptoms within recent 10 years # In pregnancy and preconception # Other conditions considered as undesirable for entry in this clinica trial
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name TAKAO Middle name Last name IMAI
Organization	Osaka University
Division name	Otolaryngology, Head & Neck Surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL	06-6879-3951
Email	timai@ent.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Takao Middle name Last name IMAI
Organization	Osaka University Hospital
Division name	Otolaryngology, Head and Neck Surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL	06-6879-5575
Homepage URL
Email	timai@ent.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
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
Address	2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
Tel	06-6879-5111
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	2018 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2012 Year 06 Month 07 Day
Date of IRB	2012 Year 06 Month 07 Day
Anticipated trial start date	2018 Year 04 Month 30 Day
Last follow-up date	2022 Year 12 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	2018 Year 04 Month 30 Day
Last modified on	2019 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036981