UMIN-CTR Clinical Trial

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

Ideopathic Sudden Sensorineural Hearing Loss (ISSHL)

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Shin-ichi Kanemaru

Institute

Department

Personal name

Organization

Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

09

Month

10

Day

Last modified on

2015

Year

09

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021935