UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007659
Receipt number R000009030
Scientific Title The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.
Date of disclosure of the study information 2012/05/10
Last modified on 2012/04/04 10:01:53

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Basic information

Public title

The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.

Acronym

The middle ear pressure therapy for intractable Meniere disease.

Scientific Title

The clinical evaluation of the middle ear pressure therapy for intractable Meniere disease.

Scientific Title:Acronym

The middle ear pressure therapy for intractable Meniere disease.

Region

Japan


Condition

Condition

Intractable Meniere disease

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical benefit of middle ear presssure therapy for intractable Meniere disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The frequency of vertigo, Functional level scale

Key secondary outcomes

DHI(dizziness handicap inventory)


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

middle ear pressure tehrapy

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

8 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Fnctional level scale is more than 3.

Key exclusion criteria

The case without informed consent.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumiyuki Goto

Organization

NHO Tokyo Medical Center

Division name

otolaryngology

Zip code


Address

2-5-1 Higashigaoka meguro

TEL

03-3411-0111

Email



Public contact

Name of contact person

1st name
Middle name
Last name FUMIYUKI GOTO

Organization

NHO TMC

Division name

otolaryngology

Zip code


Address


TEL


Homepage URL


Email

amifumi@bc5.so-net.ne.jp


Sponsor or person

Institute

TMC

Institute

Department

Personal name



Funding Source

Organization

TMC

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2012 Year 05 Month 10 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

Preinitiation

Date of protocol fixation

2012 Year 04 Month 05 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 04 Day

Last modified on

2012 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name