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

NCT06545175 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Intracochlear application of VSF1.01

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

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Nils K. Prenzler, PD DR. · Hannover Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545175 on ClinicalTrials.gov