What side effects are associated with this type of intervention?

Common treatments for cochlear hearing loss, particularly cochlear implantation, can have several side effects. Traditional cochlear implantation may involve risks such as infection, bleeding, dizziness, and potential damage to the facial nerve, which can affect facial movement. The minimally invasive, image-guided surgical approach, like the one studied with the Microtable® Microstereotactic Frame and Drill Press, aims to reduce these risks. Potential side effects of this approach include lightheadedness, tingling, and tinnitus, but it generally offers benefits such as shorter procedure time, less tissue removal, and quicker wound healing, which may lead to decreased post-operative discomfort and faster recovery.

What prior FDA approvals exist?

The FDA has approved various treatments for cochlear hearing loss, primarily focusing on cochlear implants. Traditional cochlear implantation involves more invasive surgical techniques. The Microtable® Microstereotactic Frame and Drill Press represents a novel, minimally invasive, image-guided approach for cochlear implantation, which aims to reduce procedure time, minimize tissue removal, and improve post-operative outcomes. While specific FDA approvals for this exact method are not detailed, the general trend in cochlear implant technology is towards less invasive and more precise surgical techniques to enhance patient recovery and auditory performance.

What other types of research exist?

Promising novel alternatives for cochlear implantation in 2024 include: 1) Robotic-assisted cochlear implantation, which offers high precision and consistency in electrode placement. 2) Advanced imaging techniques such as intraoperative CT or MRI to guide electrode insertion and ensure optimal placement. 3) Use of flexible electrode arrays that conform better to the cochlear anatomy, potentially improving hearing outcomes. 4) Development of less invasive surgical tools and techniques that minimize tissue damage and preserve cochlear structures.

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Procedure

Microtable® Cochlear Implantation for Hearing Loss

N/A

Waitlist Available

Led By Robert F. Labadie, MD, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 22 to 80 years of age.

Male or female 22 to 80 years of age

Must not have

Previous mastoidectomy on the ear undergoing research procedures

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-operative

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the provided information but could include typical surgical risks such as infection, discomfort at the site of surgery, taste disturbance due to nerve preservation techniques, and general anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 80 years old.

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I am between 22 and 80 years old.

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My CT scan shows normal ear and inner ear structures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a mastoidectomy on the ear being studied.

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

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I currently have a middle ear infection.

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I have a severe long-term ear condition.

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I am currently pregnant.

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I have a severe structural issue with my inner ear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful insertion of the CI electrode array into the cochlea.

Secondary study objectives

Amount of tissue removed scanning

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

Optimal electrode position within the cochlea's scala tympani scanning

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Visual assessment of electrode insertionExperimental Treatment1 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 insertionExperimental Treatment1 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cochlear hearing loss is commonly treated with cochlear implants, which involve surgically placing an electrode array within the cochlea to stimulate the auditory nerve directly. The Microtable® Microstereotactic Frame and Drill Press offers a minimally invasive, image-guided approach to cochlear implantation, which aims to reduce tissue removal, preserve critical structures like the chorda tympani nerve, and ensure consistent electrode placement. This method potentially shortens surgery and anesthesia time, decreases postoperative discomfort, and enhances wound healing. These benefits are crucial for cochlear hearing loss patients as they can lead to improved auditory outcomes and a quicker recovery, thereby enhancing overall quality of life.

Outlook and future of inner ear therapy.[Biological therapies in otology. German version].Surgical treatment of Meniere's disease.