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Trans-round Window Membrane Intracochlear Steroid

NCT07540728 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-04-20

No results posted yet for this study

Summary

Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss

Conditions

  • Sudden Hearing Loss

Interventions

DRUG

Experimental: Group A: intracochlear triamcinolone acetonide injection

intracochlear injection of triamcinolone acetonide through the round window membrane

DRUG

intracochlear injection of dexamethasone

intracochlear injection of dexamethasone through the round window membrane

DEVICE

intratympanic dexamethasone injection

intratympanic dexamethasone injection through tympanic membrane

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Yilai Shu, MD, Ph.D · Eye & ENT Hospital, Fudan University, Shanghai, China

  • Huawei Li, MD, Ph.D · Eye & ENT Hospital, Fudan University, Shanghai, China

  • Wuqing Wang, MD, Ph.D · Eye & ENT Hospital, Fudan University, Shanghai, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2028-04-20
Completion
2028-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07540728 on ClinicalTrials.gov