Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss
Reason given: This study was withdrawn before enrollment due to challenges in participant recruitment. A revised study protocol will be initiated under a new research project.
Key facts
- Phase
- Phase 1/2
Trial details
- Who runs it
- Seoul National University Hospital
- Trial code
- NCT06437054
- Record updated
- 22 May 2026
- Original description
This study is a prospective, randomized pilot study. To verify an efficacy/safety 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.Read full original descriptionShow less
Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
This study is a prospective, randomized pilot study. To verify an efficacy/safety 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.
Inclusion: 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: 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; 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; Pregnant or lactating women; Cases with posterior labyrinth lesions.