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The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.
The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.
The investigators propose this early feasibility study to determine if minimally invasive image-guided drilling to surgically access the cochlea for CI can be successfully performed. The study will involve only unilateral CI. The decision of unilateral vs. bilateral implantation is made clinically and before the patient may elect to enroll in this study. Bilateral implantation can take place either simultaneously or sequentially, with the decision made by the clinician as part of standard care.
If a participant is scheduled for routine bilateral CI, the traditional approach will be used on one side and the investigational approach on the other. Traditional surgery will be performed on the better-hearing ear, and the investigational technique will be performed on the poorer hearing ear. To minimize patient variability, the investigators will only be studying lateral wall electrodes, the Cochlear slim straight electrode and MED-EL electrodes. The investigators plan to enroll 12 cochlear implant patients in two groups. Group 1 will consist of patients implanted under direct visualization afforded by lifting a tympanomeatal flap, and Group 2 will consist of patients implanted with visualization afforded by passing an endoscope across the eardrum via a myringotomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual assessment of electrode insertion | Experimental | This arm will include the first 6 participants. In this group, a cut will be made near the eardrum and it will be lifted up so the surgeon can see the electrode as it goes into the cochlea. |
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| Camera assessment of electrode insertion | Experimental | This arm will include the next 6 participants. In this group, a tube with a camera will be inserted past the ear drum, by making a small hole in the ear drum, to see the electrode as it goes into the cochlea. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Microtable® Stereotactic System | Device | x |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful insertion of the CI electrode array into the cochlea. | Assessed by CT confirmation of intra-cochlear placement of the electrode array. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time in minutes of cochlear implant surgery. | Assessed by physical exam immediately after surgical intervention. | immediately post-operative |
| Amount of tissue removed scanning | Volume assessed by comparison of pre-operative CT scan to the post-operative CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert F. Labadie, MD, PhD | Contact | 843-792-7161 | labadie@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert F. Labadie, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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All patients who meet eligibility requirements and choose to participate will undergo the image guided surgical cochlear implantation procedure as described in the protocol.
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| pre-operative and post-operative |
| Preservation of taste scanning | Assessed by postoperative survey | 2-4 weeks post-operative |
| Optimal electrode position within the cochlea's scala tympani scanning | Assessed by intraoperative CT scan | Intraoperative |
| Avoidance of damage to the facial nerve during the image guided cochlear implantation surgery. | Assessed by physical exam immediately after surgical intervention and follow-up visits via the House-Brackmann scale. | up to 12 months post-operative |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |