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NCT03101917

Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)

Not yet recruiting NA Last updated 5 March 2025
What this trial tests

NA trial testing The Microtable® Stereotactic System in Hearing Loss, Cochlear in 12 participants. Not yet recruiting.

Timeline
1 July 2026
Primary endpoint
5 July 2028
31 July 2028

Quick facts

Lead sponsorMedical University of South Carolina
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 July 2026
Primary completion5 July 2028
Estimated completion31 July 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

Adults 22 to 80, any sex, with Hearing Loss, Cochlear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Implementation of Second-generation Minimally Invasive Image-guided Cochlear Implantation Surgery.
    Labadie RF, Riojas K, Von Wahlde K, Mitchell J, et al · · 2021 · cited 7× · PMID 33967246 · DOI 10.1097/mao.0000000000003025

Verify or expand the search:

Other recruiting trials for Hearing Loss, Cochlear

Currently open trials in the same condition.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03101917.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing