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

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ClinicalTrials.gov Identifier: NCT03101917
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Robert F. Labadie, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Cochlear Device: The Microtable® Stereotactic System Not Applicable

Detailed 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.

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
Allocation: Non-Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
x

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
x




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time in minutes of cochlear implant surgery. [ Time Frame: immediately post-operative ]
    Assessed by physical exam immediately after surgical intervention.

  2. 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

  3. Preservation of taste scanning [ Time Frame: 2-4 weeks post-operative ]
    Assessed by postoperative survey

  4. Optimal electrode position within the cochlea's scala tympani scanning [ Time Frame: Intraoperative ]
    Assessed by intraoperative CT scan

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Robert F. Labadie, MD, PhD Vanderbilt University Medical Center

Responsible Party: Robert F. Labadie, Vice Chair, Chief Research Officer, Professor of Otolaryngology-Head and Neck Surgery, Professor of Biomedical Engineering, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03101917     History of Changes
Other Study ID Numbers: 161659
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms