Actively Recruiting
Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma
Led by Hannover Medical School · Updated on 2026-02-12
11
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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 1. neural responses of auditory nerve 2. speech understanding 3. hearing thresholds 4. electrode impedances 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.
CONDITIONS
Official Title
Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men, women, inter/diverse aged �3E= 18 years
- Women without childbearing potential by surgical sterilization, hysterectomy, uterine agenesis, or postmenopausal for over 1 year if aged �3E= 50 years
- Women of childbearing potential practicing sexual abstinence, having only female or sterile male partners, or using reliable contraception if sexually active with fertile male partner
- Signed informed consent
- Functional deaf patients with profound hearing loss and candidates for cochlear implantation
You will not qualify if you...
- Prior ear surgery
- Inner ear malformations
- Acute or chronic otitis media
- Keloid disorder
- Central nervous system comorbidities
- Any malignancies
- Kidney disease with elevated creatinine >1.5x ULN or reduced kidney function
- Liver disease with elevated liver enzymes or abnormal blood clotting
- Suspected or verified pregnancy or breastfeeding
- Hypersensitivity to components of medications used including VSF1.01
- Participation in another clinical trial involving investigational drugs or devices within 30 days prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hannover Medical School, Dept. of Otorhinolaryngology
Hanover, Germany, 30625
Actively Recruiting
Research Team
N
Nils K. Prenzler, PD Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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