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Search / Trial NCT05110183

Opto-electrical Cochlear Implants

Launched by NORTHWESTERN UNIVERSITY · Oct 26, 2021

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Deaf Neural Stimulation With Light Cochlear Implant

ClinConnect Summary

The patient is admitted to one of the participating clinical centers because of a brain tumor, which requires surgery to be removed. As discussed in detail with the treating surgeon, the tumor is large, and an approach will be used that accesses the tumor from the side through the temporal bone. This approach passes by the balance and hearing organ, and the partial or complete removal of the organ responsible for balance and hearing on this side is necessary. Participation in the study will extend the time of surgery by 30 minutes. There is no special preparation and no follow-up required f...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Criterion for inclusion of a patient is the requirement of the translabyrinthine approach for tumor removal. The surgical approach is determined by the tumor size, the tumor location and the remaining hearing of the patient. Criteria for a translabyrinthine approach are:
  • 1. the tumor grows in the pontine angle and the facial nerve is at risk for damage during the surgery because the tumor is already large and in close proximity of the facial nerve AND
  • 2. the tumor is larger than 2.5 cm AND
  • 3. Pure tone hearing thresholds are elevated by at least 50 dB AND
  • 4. Speech discrimination scores are 50% or less
  • Exclusion Criteria:
  • adults unable to consent.
  • individuals who are not yet adults (infants, children, teenagers).
  • pregnant women.
  • prisoners.
  • vulnerable populations

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Columbia, Missouri, United States

Coral Gables, Florida, United States

Winfield, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Claus-Peter Richter, MD, PhD

Principal Investigator

Northwestern University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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