UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transtympanic pressure treatment in patients with intractable Meniere's disease and delayed endolymphatic hydrops
Title of the study (Brief title)	Trantympanic pressure treatment in Meniere's disease
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	Effect of transtympanic pressure treatment to cure the intractable Meniere's disease and delayed endolymphatic hydorps.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of vertigo
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Pressure treatment using by the transtympanic massage device
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Intractable Meniere's disease and delayed endolymphatic hydrops
Key exclusion criteria	Perforation of tympanic membrane
Target sample size	12

Research contact person
Name of lead principal investigator	Hideo Shojaku
Organization	University of Toyama
Division name	Department of Otolaryngology
Address	2630 Sugitani, Toyama, Toyama
TEL	0764347368
Email	hshojaku@med.u-toyama.ac.jp

Public contact
Name of contact person	Hideo Shojaku
Organization	University of Toyama
Division name	Department of Otolaryngology
Address	2630 Sugitani, Toyama, Toyama
TEL	0764347368
Homepage URL
Email	hshojaku@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	Self-raising
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 08 Month 21 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
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	2018 Year 05 Month 13 Day
Last modified on	2018 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037144