NCT05455398

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

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-11-01
• Completion: 2024-03-01
• First posted: 2022-07-13
• Last updated: 2022-07-13

Locations

1 site across 1 country: China