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Intratympanic Administration Steroid by Gelatin Sponge for Ideopathic Sudden Sensorineural Hearing Loss

Intratympanic Administration Steroid by Gelatin Sponge for Ideopathic Sudden Sensorineural Hearing Loss - i-Tass Therapy for ISSHL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018974
Enrollment
30
Registered
2015-09-10
Start date
2015-07-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ideopathic Sudden Sensorineural Hearing Loss (ISSHL)

Interventions

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 int

Sponsors

Shin-ichi Kanemaru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactShin-ichi Kanemaru

Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital Otolaryngolory, Head and Neck Surgery

kanemaru@ent.kuhp.kyoto-u.ac.jp06-6312-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026