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About
The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation.
The main questions it aims to answer are:
Primary objective:
Safety of intracochlear application of VSF1.01 in patients receiving cochlear implantation
Secondary objectives:
Effectiveness on
During cochlear implant operation, patients receive as adjuvant treatment intracochlear VSF1.01 prior to insertion of the electrode array.
Cochlear implantation is conducted according to the clinical standard at the investigational site.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Men, women, inter/diverse aged ≥ 18 years
Women without childbearing potential defined as follows:
Women of childbearing potential:
Signed written informed consent from subjects capable of understanding all information and to give full informed consent
Functional deaf patients (profound hearing loss with or without non-functional residual hearing in the low frequencies i.e. 125 Hz: 45 dB - 95 dB; 250 Hz: 50 dB - 105 dB; 500 Hz: 55 dB - 110 dB; 750 Hz and higher: 65 dB or below) that are candidates for cochlear implantation
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
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Central trial contact
Nils K. Prenzler, PD Dr.
Data sourced from clinicaltrials.gov
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