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NOT YET RECRUITING
NCT03101917
NA

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

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

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.

Official title: Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation

Key Details

Gender

All

Age Range

22 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-07-01

Completion Date

2028-07-31

Last Updated

2025-03-05

Healthy Volunteers

No

Interventions

DEVICE

The Microtable® Stereotactic System

x

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States