Status:
RECRUITING
CI Following VS Removal or Labyrinthectomy
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Advanced Bionics
Conditions:
Vestibular Schwannoma
Meniere Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor...
Eligibility Criteria
Inclusion
- Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician
- Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy
- Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences
- For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve
Exclusion
- Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas
- Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma
- Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation
- Active middle ear disease
- Greater than 70 years of age
- Vestibular schwannoma greater than 2 cm
- Patient refusal of receiving pneumococcal vaccine
- Any contra-indication(s) for undergoing surgery.
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03795675
Start Date
January 14 2019
End Date
December 31 2027
Last Update
March 19 2025
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210