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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021233
Receipt No. R000024494
Scientific Title Evaluation of different materials for aural fullness treatment and the effect of local anesthetics as its diagnostic tool
Date of disclosure of the study information 2018/04/01
Last modified on 2016/02/27

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Basic information
Public title Evaluation of different materials for aural fullness treatment and the effect of local anesthetics as its diagnostic tool
Acronym Aural fullness treatment with a tympanic membrane patch and its diagnosis with local anesthetics.
Scientific Title Evaluation of different materials for aural fullness treatment and the effect of local anesthetics as its diagnostic tool
Scientific Title:Acronym Aural fullness treatment with a tympanic membrane patch and its diagnosis with local anesthetics.
Region
Japan

Condition
Condition Disorders presenting aural fullness
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessing the value of the local anesthetics of the tympanic membrane as the differential diagnostic tool for aural fullness.
Assessing the value of the tympanic membrane patch for aural fullness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of the extent of relieving by the local anesthetics and diagnostic criteria of the patients
Key secondary outcomes Correlation of the extent of relieving by the tympanic membrane patch and diagnostic criteria of the patients

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The local anesthetics of the tympanic membrane
Tympanic membrane patch
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Complaining aural fullness or similar symptoms
2) 16 years or older when registering
3) Capable to submit a written consent form
4) Capable to be present at ENT clinic of Nagoya City University Hospital.
Key exclusion criteria 1) Tympanic membrane with perforation
2) Presenting sensory symptoms due to systemic neurological, psychological or collagen diseases
3) Severe infectious disease
4) Medications with potential complications for the sensory systems
5) Diabetes that is poorly controlled
6) Hepatic disease (AST >100U and/or ALT 100U)
7) Renal malfunction (BUN>25mg/ml and/or serum Cre level> 2.0,g/dl)
8) Impaired wound healing
9) Pregnant, or potentially pregnant woman
10) Participating other clinical trials within three months prior to the trial
11) Allergy to the amide type local anesthetics and metals
12) Taking loop diuretics, thiazide, isosorbide or other drugs separately specified.
13) Presenting acute/chronic otitis media, external otitis, tympanic membrane inflammation and aural diseases separately specified.
14) Heart pacer implantation
15) Carrying other medical issues the investigator considered not suitable for the trial

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Murakami
Organization Nagoya City University Hospital
Division name Department of Otolaryngology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8256
Email meijo_ent@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Inagaki
Organization Nagoya City University Hospital
Division name Department of Otolaryngology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8256
Homepage URL
Email meijo_ent@hotmail.com

Sponsor
Institute Department of Otolaryngology, Nagoya City University, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization
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
2018 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 02 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
2016 Year 02 Month 27 Day
Last modified on
2016 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024494

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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