Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma (NCT06545175) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma
Germany10 participantsStarted 2024-11-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men, women, inter/diverse aged ≥ 18 years
* Women without childbearing potential defined as follows:
* at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
* hysterectomy or uterine agenesis or
* ≥ 50 years and in postmenopausal state \> 1 year or
* Women of childbearing potential:
* who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
* who have sexual relationships with female partners only and/or with sterile male partners or
* who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.
* 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:
* Patients with prior ear surgery
* Patients with inner ear malformations
* Patients with acute or chronic otitis media
* Patients with keloid disorder
* Comorbidities concerning the central nervous system
* Malignancies of any type
* Kidney disease with elevated blood values: creatin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate and severity of (serious) adverse events
Timeframe: Continuously from start to end of study [Start: IMP treatment (day 0), end of the study (Follow-up 5)], assessed up to approximately 6 months