Maintaining Cochlear Patency After VIIIth Nerve Surgery

NCT03261726 | Withdrawn DMC FDA Device

• 1 other identifier: IRB# 1040241
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in \~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.

Conditions

Acoustic Neuroma; Labyrinthitis Ossificans; Profound Hearing Impairment

Keywords

unilateral deafness; acoustic neuroma; cochlear implant

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode

  Office visits and MRI monitoring: 1. 2 - 3 weeks after surgery: Routine post-operative visit for wound care. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. 2. 3 - 4 months after surgery: Monitoring MRI with and without contrast of the inner ear/internal auditory canals with routine post-operative visit. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images. 3. Study Endpoint: 1 year after surgery. Repeat MRI with and without contrast of the inner ear/internal auditory canals. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.

  One year postoperatively

Secondary Outcomes (1)

• Presence or absence of fluid in the cochlea

  3- 4 months and 1 year after tumor removal and implantation of the insertion electrode

Study Arms (1)

MedEl Test Electrode Placer

EXPERIMENTAL

MedEl Test Electrode Placed at VIIIth nerve tumor resection

Device: MedEl Test Electrode Placer

Interventions

MedEl Test Electrode Placer DEVICE

This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.

MedEl Test Electrode Placer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of all ages with unilateral or bilateral acoustic neuromas who face loss of hearing in 1 ear from surgical removal via a translabyrinthine approach.
• patients do not meet criteria for conventional cochlear implantation or auditory brainstem implantation.
• tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve.
• the patient must be willing to undergo preoperative S pneumococcus immunization protocol recommended by the US CDC immunization recommendations for cochlear implant patients.

You may not qualify if:

• inability to preserve the auditory division of the VIIIth cranial nerve during tumor removal ossification or fibrosis of the cochlea found on preoperative imaging (CT or MRI) that precludes cochlear implantation.
• active middle ear disease.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Med-El Corporation: collaborator

Study Sites (1)

The Michigan Ear Institute

Farmington Hills, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric W Sargent, MD

  Ascension Providence Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 25, 2017
• Study Start: August 4, 2017
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: December 19, 2025

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)