Maintaining Cochlear Patency After VIIIth Nerve Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03261726|
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : January 14, 2019
|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)|
|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|
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.
- Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode [ Time Frame: One year postoperatively ]
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.
- 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.
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
|Contact: Marianne Lahey||248.465.4828||Marianne.Lahey@ascension.org|
|United States, Michigan|
|The Michigan Ear Institute||Recruiting|
|Farmington Hills, Michigan, United States, 48334|
|Contact: Marianne Lahey 248-465-4828 Marianne.Lahey@ascension.org|
|Principal Investigator:||Eric W Sargent, MD||Ascension Providence Hospital|