New drill aims to make cochlear implants quicker and gentler
NCT ID NCT03101917
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study tests a new surgical device called the Microtable® Stereotactic System for cochlear implants. The device uses a custom-made frame to guide a drill precisely to the inner ear, potentially making surgery faster, less painful, and better at preserving taste. The study will enroll 12 adults who are already eligible for a cochlear implant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Microtable® Stereotactic System (a surgical device)
- What this could lead to
- If successful, this device could make cochlear implant surgery less invasive, with faster recovery and better taste preservation.
- What could go wrong
- This is a very early feasibility study with only 12 participants, so results may not apply broadly. The device is new and its safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female 22 to 80 years of age. * Able to complete study related procedures. * Able to provide written informed consent. * Eligible for cochlear implant surgery as per routine pre-operative CI evaluation/workup. If patient is a candidate for bilateral CI, the research technique will be performed unilaterally on the side with the most favorable anatomy and/or worst residual hearing. * Pre-operative CT scan of head/temporal bone as part of routine care showing normal temporal bone and intra-cochlear anatomy. * Scheduled to receive either a Cochlear CI522 with the slim straight electrode or a MED-EL Synchrony with standard, Flex 24, or Flex 28 electrode. Exclusion Criteria: * Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing. * ASA (American Society of Anesthesiologists) Physical Status classification of 4 or above or determined by surgeon to be too great of a health risk. * Previous mastoidectomy on the ear undergoing research procedures. * Severe anatomical abnormality of the temporal bone including but not limited to: 1) Mondini malformation 2) common cavity malformation 3) enlarged vestibular aqueducts (EVA) and/or 4) cochlea ossification. * Severe chronic ear disease. * Active middle ear infection. * Subjects without a favorable trajectory based on pre-operative imaging, analysis and planning with favorable trajectory defined as a linear track extending from the surface of the mastoid cortex, through the facial recess, and targeting the basal turn of the cochlea without violation of the external auditory canal, sigmoid sinus, tegmen, and/or facial nerve.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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