Microtable® Cochlear Implantation for Hearing Loss

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, less invasive method for cochlear implantation to assist those with hearing loss. The study aims to make the surgery quicker and more comfortable, offering benefits like faster healing and improved hearing results. Participants will be divided into two groups to test different electrode insertion methods: one using visual assessment and the other using a camera. Ideal candidates are those already scheduled for cochlear implant surgery and have a CT scan showing normal ear anatomy. The Microtable® Stereotactic System, a specialized tool for precise implantation, is used in this study. As an unphased trial, this study allows participants to contribute to innovative surgical advancements that could enhance future cochlear implant procedures.

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.

What prior data suggests that the Microtable® Stereotactic System is safe for cochlear implantation?

Research has shown that the Microtable® Stereotactic System, a new tool for cochlear implants, aims to make surgery less invasive. This tool uses a special frame to help place the implant more accurately. Although specific safety data for this system is not yet available, robotic systems for cochlear implants generally aim to lower surgery risks.

A review of 31,857 issues with cochlear implants identified some problems with certain manufacturers, but these involved different systems, not the Microtable®. This new system remains in early testing, with the primary goal of assessing its safety and effectiveness. Early trials like this one often focus on understanding safety to ensure that the treatment is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Microtable® Cochlear Implantation because it introduces innovative techniques to improve cochlear implant accuracy. Unlike traditional methods where surgeons insert electrodes relying on indirect visualization, this trial explores direct visual assessments. One method involves lifting the eardrum to allow the surgeon to see the electrode insertion directly, while another uses a tiny camera inserted through the eardrum for real-time visualization. These approaches aim to enhance precision and potentially improve hearing outcomes for patients with hearing loss.

What evidence suggests that the Microtable® Stereotactic System is effective for cochlear implantation?

Research has shown that the Microtable® Stereotactic System could make cochlear implant surgeries more precise and less invasive. By using a custom frame, it helps doctors target the inner ear more accurately. This method may shorten surgery time and reduce the amount of tissue removed, leading to quicker healing and less discomfort afterward. The device aims to place electrodes more consistently, which studies suggest may improve hearing results after surgery. In this trial, participants will be divided into two groups: one group will undergo visual assessment of electrode insertion, and the other will have camera assessment of electrode insertion. Initial evaluations of similar systems have shown promising results in improving surgical outcomes for patients needing cochlear implants. ^{1 2 4 5 6}

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.

Able to complete study related procedures.

Able to provide written informed consent.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03101917

Microtable® Method for Cochlear Implantation ... The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame ...

2. withpower.com withpower.com/trial/phase-hearing-loss-1-2020-66597

Microtable® Cochlear Implantation for Hearing Loss This trial tests a custom-made device that helps doctors perform more precise and less invasive cochlear implant surgeries. It targets patients who need ...

3. mdpi.com mdpi.com/2079-9292/14/13/2685

Robotic Systems for Cochlear Implant Surgeries: A Review ... This review evaluates robotic systems developed for cochlear implantation, focusing on their design, surgical integration, and clinical outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6792393/

Long-Term Outcomes of Cochlear Implantation in Patients ... Results demonstrate long-term success of patients with high-frequency hearing loss following Hybrid L24 (Cochlear) cochlear implantation.

5. ieeexplore.ieee.org ieeexplore.ieee.org/iel7/10/9998557/09851918.pdf

Ex Vivo Evaluation of a Minimally Invasive Approach for ... Herein, we describe the design of a new micro- stereotactic targeting system dedicated to cochlear im- plant (CI) surgery and its experimental evaluation in an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11185016/

Safety and Early Outcomes of Cochlear Implantation ... Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were ...