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Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss

NCT05455398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2022-07-13

No results posted yet for this study

Summary

The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy

Conditions

  • Hearing Loss, Sudden

Interventions

PROCEDURE

Surgical treatment of round window niche enlargement via round window for inner ear drug delivery

The round window niche is surgically removed and the hormone is slowly released into the inner ear using a gelatin sponge that has absorbed the hormone in the round window

PROCEDURE

Drum chamber drug injection

Injection of drugs into the tympanic chamber through the tympanic membrane

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Zhigang ZHANG, master · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-11-01
Completion
2024-03-01

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 NCT05455398 on ClinicalTrials.gov