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Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma

ConditionHearing Loss
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHannover Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men, women, inter/diverse aged ≥ 18 years

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

Disqualifiers

Patients with prior ear surgery

Patients with inner ear malformations

Patients with acute or chronic otitis media

Patients with keloid disorder

Trial design

Design model

Single group

Treatments tested in this trial

  • Intracochlear application of VSF1.01

    Drug

    During cochlear implant operation, patients receive intracochlear VSF1.01 prior to insertion of the electrode array.

Treatment groups

11 Participants
are divided into 1 treatment group
Group A: Intracochlear treatment with VSF1.01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate and severity of (serious) adverse events

Recording and documentation of number and severity of (serious) adverse events

Time frame
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

Secondary outcomes

1

Evaluation of eCAP growth function

Assessment of effectiveness on neural responses of auditory nerve by measuring electrically evoked compound action potential (eCAP; eCAP growth function)

Time frame
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
2

Evaluation of speech perception

Assessment of effectiveness on speech understanding by measuring speech perception (in quiet and in noise) by HSM 10dB SNR/5dB SNR, FBM, OLSA 50%

Time frame
From Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months
3

Measurement of air and bone conduction

Assessment of effectiveness on hearing thresholds by measuring air and bone conduction from 125 Hz - 16,000 Hz by pure tone audiometry

Time frame
At Screening/baseline and from Day 1 (FU 1) to end of study (FU 5), assessed up to approximately 6 months
4

Measurement of impedance levels

Assessment of effectiveness on electrode impedances by determination of impedance levels (as measure to rule out pathological levels and as part of clinical routine)

Time frame
From Day 0 to end of study (FU 5), assessed up to approximately 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hannover Medical School

Lead sponsor

Source ClinicalTrials.gov
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