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Clinical Trials/NCT06306534
NCT06306534
Recruiting
N/A

Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation

Hannover Medical School1 site in 1 country10 target enrollmentMay 15, 2023
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ConditionsAuditory; Nerve

Overview

Phase
N/A
Intervention
Not specified
Conditions
Auditory; Nerve
Sponsor
Hannover Medical School
Enrollment
10
Locations
1
Primary Endpoint
Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
March 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Written informed consent
  • •Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
  • •Age ≥ 18 years
  • •Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

Exclusion Criteria

  • •Disabilities in addition to hearing impairment which might interfere with the study procedure
  • •Pregnant and breast feeding woman or other vulnerable population

Outcomes

Primary Outcomes

Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms

Time Frame: 4 weeks

Secondary Outcomes

  • Collection of adverse events(4 weeks)

Study Sites (1)

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