Microtable® Cochlear Implantation for Hearing Loss

Recruiting at 1 trial location

Overseen By Kate Von Wahlde, MJ, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Pregnancy, ASA 4+, Mastoidectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a custom-made device that helps doctors perform more precise and less invasive cochlear implant surgeries. It targets patients who need cochlear implants and may benefit from quicker recovery and fewer complications. The device uses imaging to guide a drill for accurate surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Microtable® Cochlear Implantation generally safe for humans?

The Microtable® system, used in minimally invasive cochlear implant surgeries, aims to reduce trauma to the ear's structures. However, in early trials, there was an incident of temporary facial nerve weakness, which led to changes in the procedure to improve safety. ^{1 2 3 4 5}

How is the Microtable® Stereotactic System treatment different from other cochlear implant treatments?

The Microtable® Stereotactic System is unique because it uses a patient-specific, minimally invasive approach with a customized microstereotactic frame to precisely guide the surgical drill, reducing trauma to surrounding structures and improving accuracy compared to traditional methods. ^{1 6 7 8 9}

What data supports the effectiveness of the Microtable® Stereotactic System treatment for hearing loss?

The research on laser-microtextured implants, which are similar in concept to the Microtable® Stereotactic System, shows stable or improved tissue parameters over time, suggesting potential effectiveness in maintaining or enhancing tissue health. ^{10 11 12 13 14}

Who Is on the Research Team?

Robert F. Labadie, MD, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 80 who need cochlear implant surgery and have normal temporal bone anatomy as shown by a CT scan. It's not for pregnant women, those with severe health risks or ear abnormalities like Mondini malformation, or if the surgical path isn't clear on imaging.

Inclusion Criteria

I am approved for cochlear implant surgery after a standard evaluation.

I am between 22 and 80 years old.

Able to complete study related procedures.

Exclusion Criteria

I have had a mastoidectomy on the ear being studied.

My pre-surgery scans show a safe path for ear surgery without risking important structures.

I currently have a middle ear infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cochlear implantation using the Microtable® method, with either visual or camera assessment of electrode insertion

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including avoidance of facial nerve damage and preservation of taste

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• The Microtable® Stereotactic System

Trial Overview The Microtable® System is being tested to see if it can make cochlear implant surgeries less invasive. The system uses a custom frame and drill press guided by images to place an electrode in the ear, which may lead to quicker procedures and better outcomes.

How Is the Trial Designed?

Group I: Visual assessment of electrode insertion Experimental Treatment 1 Intervention

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.

Group II: Camera assessment of electrode insertion Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A review of 31,857 adverse events from cochlear implants revealed that implants from manufacturer C had a higher incidence of complications, including infection (0.97%), cerebrospinal fluid leak (0.07%), extrusion (0.44%), and facial nerve stimulation (0.11%).

Manufacturer B's implants were linked to a higher rate of meningitis (0.07%), highlighting the importance of considering both patient risk factors and the specific manufacturer when evaluating the safety of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. Jinka, S., Wase, S., Jeyakumar, A.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Crestal Bone and Keratinized Tissue Around 3.0-mm Laser-Microtextured Dental Implants After 1 Year in Function: A Case Series. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of Platform-Switched, Laser-Microtextured Implant on Marginal Bone Level: A 24-Month Case Series Study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Narrow-diameter implants with conical connection for restoring the posterior edentulous region. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Prospective Clinical and Radiographic Assessment of Platform-Switched Laser-Microchannel Implants Placed in Limited Interimplant Spaces. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Experience With the New Active Transcutaneous Bone-Conduction Implant With Smaller Dimensions. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Drilling accuracy evaluation of a mouldable surgical targeting system for minimally invasive access to anatomic targets in the temporal bone. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes with the Kanso™ off-the-ear cochlear implant sound processor. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Second-generation Minimally Invasive Image-guided Cochlear Implantation Surgery. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Implications of minimizing trauma during conventional cochlear implantation. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Temporal bone microdissection for anatomic study of cochlear implant electrodes. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Ex Vivo Evaluation of a Minimally Invasive Approach for Cochlear Implant Surgery. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Percutaneous cochlear implant drilling via customized frames: an in vitro study. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Clinical validation study of percutaneous cochlear access using patient-customized microstereotactic frames. [2021]