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

NCT03101917 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 161659
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Cochlear

Outcome Measures

Primary Outcomes (1)

• Successful insertion of the CI electrode array into the cochlea.

  Assessed by CT confirmation of intra-cochlear placement of the electrode array.

  Intraoperative

Secondary Outcomes (5)

• Time in minutes of cochlear implant surgery.

  immediately post-operative

• Amount of tissue removed scanning

  pre-operative and post-operative

• Preservation of taste scanning

  2-4 weeks post-operative

• Optimal electrode position within the cochlea's scala tympani scanning

  Intraoperative

• Avoidance of damage to the facial nerve during the image guided cochlear implantation surgery.

  up to 12 months post-operative

Study Arms (2)

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.

Device: The Microtable® Stereotactic System

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.

Device: The Microtable® Stereotactic System

Interventions

The Microtable® Stereotactic System DEVICE

x

Camera assessment of electrode insertion; Visual assessment of electrode insertion

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert F. Labadie, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert F. Labadie, MD, PhD

CONTACT

843-792-7161; labadie@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Dept of O-HNS

Model Details: All patients who meet eligibility requirements and choose to participate will undergo the image guided surgical cochlear implantation procedure as described in the protocol.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 5, 2017
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 5, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)