Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437054
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-24
Brief Title:
Verification of the EfficacySafety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Verification of the EfficacySafety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective randomized pilot study To verify an efficacysafety of the mixed drug injectable delivery vehicle for treating intractable hearing loss Hearing test endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation
Detailed Description:
The goal of this clinical trial pilot study is to evaluate the Efficacy and Safety of Combined Hyaluronic Acid and Dexamethasone Treatment in Patients with Hearing Loss The main questions it aims to answer are Q1 Verification of safety Q2 Therapeutic effect of drug injection on sensorineural hearing loss Participants will undergo several assessment tests Verification of adverse effects in the external and middle ear through endoscopy Confirmation of adverse effects through imaging Hearing test to check for additional hearing loss Check if subjective ear fullness persists for more than a week aside from the drug effect If there is a comparison group Researchers will compare dexamethasone and hyaluronic acid to verify hearing improvement and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None