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

Study acronym: ESCRT
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary and study completion pushed from Jun 2026 to Oct 28, 2026
    • Enrollment target: estimated 11 to confirmed 10
    • Site details revised
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Nov 18, 2024
    v3
  4. Start date: Aug 2024 to Oct 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06545175
Lead Sponsor Hannover Medical School
Conditions
(from sponsor)		 Hearing Loss
Related terms Hearing Loss
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov