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Maintaining Cochlear Patency After VIIIth Nerve Surgery

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ClinicalTrials.gov Identifier: NCT03261726
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Med-El Corporation
Information provided by (Responsible Party):
Eric W. Sargent, MD, Ascension St John Providence

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.

Condition or disease Intervention/treatment Phase
Acoustic Neuroma Labyrinthitis Ossificans Profound Hearing Impairment Device: MedEl Test Electrode Placer Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintaining Cochlear Patency After VIIIth Nerve Surgery
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : August 4, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
Experimental: MedEl Test Electrode Placer
MedEl Test Electrode Placed at VIIIth nerve tumor resection
Device: MedEl Test Electrode Placer
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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode [ Time Frame: One year postoperatively ]

    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.


Secondary Outcome Measures :
  1. Presence or absence of fluid in the cochlea [ Time Frame: 3- 4 months and 1 year after tumor removal and implantation of the insertion electrode ]
    Appearance of the implanted cochlea on heavily T2-weighted monitoring MRI 3-4 months after surgery and 1 year after surgery.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261726


Contacts
Contact: Jennifer Monitz, CCRP 248.465.4828 Jennifer.Monitz@ascension.org

Locations
United States, Michigan
The Michigan Ear Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Jennifer L Monitz, CCRP    248-465-4828    Jennifer.Monitz@ascension.org   
Sponsors and Collaborators
Eric W. Sargent, MD
Med-El Corporation
Investigators
Principal Investigator: Eric W Sargent, MD Providence-Providence Park Hospital

Responsible Party: Eric W. Sargent, MD, Clinical Researcher, Ascension St John Providence
ClinicalTrials.gov Identifier: NCT03261726     History of Changes
Other Study ID Numbers: IRB# 1040241
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Eric W. Sargent, MD, Ascension St John Providence:
unilateral deafness
acoustic neuroma
cochlear implant

Additional relevant MeSH terms:
Neuroma
Hearing Loss
Deafness
Neuroma, Acoustic
Labyrinthitis
Labyrinth Diseases
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Otitis