Otorhinolaryngological surgery – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 10:28:34 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Otorhinolaryngological surgery – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on VSF1.01 for Reducing Surgery Trauma in Hearing Loss Patients Receiving Cochlear Implants https://clinicaltrials.eu/trial/study-on-vsf1-01-for-reducing-surgery-trauma-in-hearing-loss-patients-receiving-cochlear-implants/ Wed, 29 Apr 2026 14:23:15 +0000 https://clinicaltrials.eu/trial/study-on-vsf1-01-for-reducing-surgery-trauma-in-hearing-loss-patients-receiving-cochlear-implants/ This clinical trial is focused on studying the effects of a new treatment for people with hearing loss who are undergoing cochlear implant surgery. The treatment being tested is called VSF1.01, which is a solution for injection derived from the conditioned medium of adult human umbilical cord-derived mesenchymal stromal cells. The purpose of the study is to evaluate the safety of injecting VSF1.01 directly into the cochlea, which is the part of the inner ear involved in hearing, during the cochlear implant procedure.

Participants in the study will receive an injection of VSF1.01 during their cochlear implant surgery. The study will monitor the safety of this treatment by recording any adverse events, which are unexpected medical problems that may occur during the study. The study will also assess the health of the auditory nerve, which is responsible for transmitting sound signals to the brain, and evaluate speech perception in both quiet and noisy environments. Additionally, hearing thresholds will be measured using a method called pure tone audiometry, and the impedance levels of the electrode contacts will be checked to ensure they are functioning properly.

This study aims to provide valuable information about the safety of using VSF1.01 as an additional treatment during cochlear implant surgery. The findings could potentially lead to improved outcomes for individuals with hearing loss who are candidates for cochlear implants. The study is expected to continue until June 2026, with recruitment starting in September 2024.

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