Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03101917|
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2017
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Cochlear||Device: The Microtable® Stereotactic System||Not Applicable|
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. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients who meet eligibility requirements and choose to participate will undergo the image guided surgical cochlear implantation procedure as described in the protocol.|
|Masking:||None (Open Label)|
|Official Title:||Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Visual assessment of electrode insertion
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.
Device: The Microtable® Stereotactic System
Experimental: Camera assessment of electrode insertion
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.
Device: The Microtable® Stereotactic System
- Successful insertion of the CI electrode array into the cochlea. [ Time Frame: Intraoperative ]Assessed by CT confirmation of intra-cochlear placement of the electrode array.
- Time in minutes of cochlear implant surgery. [ Time Frame: immediately post-operative ]Assessed by physical exam immediately after surgical intervention.
- Amount of tissue removed scanning [ Time Frame: pre-operative and post-operative ]Volume assessed by comparison of pre-operative CT scan to the post-operative CT scan
- Preservation of taste scanning [ Time Frame: 2-4 weeks post-operative ]Assessed by postoperative survey
- Optimal electrode position within the cochlea's scala tympani scanning [ Time Frame: Intraoperative ]Assessed by intraoperative CT scan
- Avoidance of damage to the facial nerve during the image guided cochlear implantation surgery. [ Time Frame: up to 12 months post-operative ]Assessed by physical exam immediately after surgical intervention and follow-up visits via the House-Brackmann scale.
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): NCT03101917
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Robert F. Labadie, MD, PhD||Vanderbilt University Medical Center|