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Maintaining Cochlear Patency After VIIIth Nerve Surgery

Primary Purpose

Acoustic Neuroma, Labyrinthitis Ossificans, Profound Hearing Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MedEl Test Electrode Placer
Sponsored by
Eric W. Sargent, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acoustic Neuroma focused on measuring unilateral deafness, acoustic neuroma, cochlear implant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Michigan Ear Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MedEl Test Electrode Placer

Arm Description

MedEl Test Electrode Placed at VIIIth nerve tumor resection

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode
Office visits and MRI monitoring: 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. 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. 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

Presence or absence of fluid in the cochlea
Appearance of the implanted cochlea on heavily T2-weighted monitoring MRI 3-4 months after surgery and 1 year after surgery.

Full Information

First Posted
August 20, 2017
Last Updated
March 10, 2021
Sponsor
Eric W. Sargent, MD
Collaborators
Med-El Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03261726
Brief Title
Maintaining Cochlear Patency After VIIIth Nerve Surgery
Official Title
Maintaining Cochlear Patency After VIIIth Nerve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects were enrolled.
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
March 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric W. Sargent, MD
Collaborators
Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acoustic Neuroma, Labyrinthitis Ossificans, Profound Hearing Impairment
Keywords
unilateral deafness, acoustic neuroma, cochlear implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MedEl Test Electrode Placer
Arm Type
Experimental
Arm Description
MedEl Test Electrode Placed at VIIIth nerve tumor resection
Intervention Type
Device
Intervention Name(s)
MedEl Test Electrode Placer
Intervention Description
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 Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode
Description
Office visits and MRI monitoring: 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. 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. 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.
Time Frame
One year postoperatively
Secondary Outcome Measure Information:
Title
Presence or absence of fluid in the cochlea
Description
Appearance of the implanted cochlea on heavily T2-weighted monitoring MRI 3-4 months after surgery and 1 year after surgery.
Time Frame
3- 4 months and 1 year after tumor removal and implantation of the insertion electrode

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric W Sargent, MD
Organizational Affiliation
Ascension Providence Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Michigan Ear Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Maintaining Cochlear Patency After VIIIth Nerve Surgery

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