Verification of the Efficacy/safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new treatment for people with certain types of hearing loss that are difficult to manage with standard therapies. Specifically, it aims to test a mixed drug injectable delivery system to see if it can help restore hearing for those with conditions like sudden hearing loss, Meniere's disease, and other types of hearing loss caused by noise or medications. The trial will involve a series of tests, including hearing tests, ear examinations, and CT scans, to assess how well the treatment works and if it is safe.

To be eligible for this study, participants should be between the ages of 69 and 39 and have experienced specific kinds of hearing loss that haven’t improved with current treatments. However, certain individuals, such as pregnant women, those with specific ear problems, or serious medical conditions, will not be able to participate. This trial is not yet recruiting participants, but it offers a potential new option for those struggling with intractable hearing loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with sudden hearing loss, Meniere's disease, ototoxic hearing loss, and noise-induced hearing loss of 25dB HL at the frequency at which hearing loss occurs as a result of pure tone hearing test
• • Patients whose original hearing ability has not been restored with existing standard treatment (oral, intravenous steroids)
• • Those who have not participated in clinical trials within 3 months are selected as subjects
• Exclusion Criteria:
• • Pregnant or lactating women
• • When accompanied by lesion, infection, or anatomical deformity of the outer ear, middle ear, or inner ear
• • Those with liver disease or metabolic disease or a history thereof
• • History of hypersensitivity to indocyanine green or iodine hypersensitivity
• • History of ear surgery
• • Cases with posterior labyrinth lesions
• • Patients with a history of hypersensitivity to the ingredients of this drug
• • In addition, serious diseases such as end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive hemorrhage, and progressive cerebral hemorrhage are included Cases with brain disease and cancer are excluded from the study