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Withdrawn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
About this trial
This is an interventional treatment trial for Acoustic Neuroma focused on measuring unilateral deafness, acoustic neuroma, cochlear implant
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.
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
NCT ID
NCT03261726
First Posted
August 20, 2017
Last Updated
March 10, 2021
Sponsor
Eric W. Sargent, MD
Collaborators
Med-El Corporation
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
Learn more about this trial
Maintaining Cochlear Patency After VIIIth Nerve Surgery
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