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Search / Trial NCT06437054

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

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Trial Information

Current as of March 14, 2025

Not yet recruiting

Keywords

Drug Delivery Dexamethasone Hyaluronic Acid

ClinConnect Summary

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...

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

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

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Timeline

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Trial launched

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Estimated completion

Not reported

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