UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021233 |
|---|---|
| Receipt number | 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 20:33:33 |
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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
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
meijo_ent@hotmail.com
Sponsor or person
Institute
Department of Otolaryngology, Nagoya City University, Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024494
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
