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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018974
Receipt No. R000021935
Scientific Title Intratympanic Administration Steroid by Gelatin Sponge for Ideopathic Sudden Sensorineural Hearing Loss
Date of disclosure of the study information 2015/09/10
Last modified on 2015/09/10

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Basic information
Public title Intratympanic Administration Steroid by Gelatin Sponge for Ideopathic Sudden Sensorineural Hearing Loss
Acronym i-Tass Therapy for ISSHL
Scientific Title Intratympanic Administration Steroid by Gelatin Sponge for Ideopathic Sudden Sensorineural Hearing Loss
Scientific Title:Acronym i-Tass Therapy for ISSHL
Region
Japan

Condition
Condition Ideopathic Sudden Sensorineural Hearing Loss (ISSHL)
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess efficacy and safety of this treatment that gelatin sponges with steroid put in the tympanic cavity for the purpose of administration of high dose steroid into the inner ear through the round window for ISSHL
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A hearing test is performed at the end of one course,one or two weeks, one, 2, 3 and 6 months after the treatment.
The results of this treatment are compared with those of the cases with systemic steroids the historical control in the following items; cure rates, recovery rates and incidence of complications.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Myringotomy is performed at the start of treatment.
Gelatin sponge saturating dexamethasone is put in the tympanic cavity
This procedure is performed after myrigotomy.
Dexamethasone is injected into tympanic cavity every few days. These are performed at least five times.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who are diagnosed as ISSHL and who have some diseases showing below which would become worse by systemic steroids.
Age ; elder than 75 years old
Diabetes which is not controlled well
Gastric or duodenum ulcer
Severe infection ; virus hepatitis or tuberculosis etc.
Severe bone disease; Idiopathic Osteonecrosis of Femoral Head etc.
Sever heart disease
Thrombosis ; cerebral thrombosis or deep vein thrombosis etc.
Auto Immune disease
Severe dermatoid disease; atopic dermatitis etc.
Patients who are diagnosed as systemic steroid administration is improper for by other disease

2. Patients with ISSHL whose hearing loss has been not improved by systemic steroids and their hearing loss occurred within three weeks

3.Patients whom we get consent about this treatment

Patients who meet the criteria 1 and 3 or the criteria 2 and 3 will be enrolled in this study.
Key exclusion criteria 1.Patients who have anaphylaxis of dexamethasone
2.Patients who have middle ear infection obviously
3.Patients who have organic ear disease which would affect hearing loss; acoustic tumor, malformation of inner ear

Patients who meet the either criteria will be excluded in this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichi Kanemaru
Organization Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name Otolaryngolory, Head and Neck Surgery
Zip code
Address 2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN,530-8480
TEL 06-6312-1221
Email kanemaru@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichi Kanemaru
Organization Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name Otolaryngolory, Head and Neck Surgery
Zip code
Address 2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN,530-8480
TEL 06-6312-1221
Homepage URL
Email kanemaru@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Shin-ichi Kanemaru
Institute
Department

Funding Source
Organization Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Organization
Division
Category of Funding Organization Non profit foundation
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
2015 Year 09 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 11 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
2015 Year 09 Month 10 Day
Last modified on
2015 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021935

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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