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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-operative
Awards & highlights
Study Summary
This trial is testing a new, less invasive way to do cochlear implants that may have some benefits over traditional 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 22 and 80 years old.
Select...
I am between 22 and 80 years old.
Select...
My CT scan shows normal ear and inner ear structures.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful insertion of the CI electrode array into the cochlea.
Secondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,248 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,180 Total Patients Enrolled
Robert F. Labadie, MD, PhDPrincipal InvestigatorMedical University of South Carolina
4 Previous Clinical Trials
155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am approved for cochlear implant surgery after a standard evaluation.I currently have a middle ear infection.I am between 22 and 80 years old.I am a candidate for cochlear implant surgery based on my evaluation.I have a severe long-term ear condition.My CT scan shows normal ear and inner ear structures.I am currently pregnant.You have a high risk of health problems according to the doctor's evaluation.I am between 22 and 80 years old.Planning to get a specific type of cochlear implant with certain electrodes.My CT scan shows normal ear and inner ear structures.I have a severe structural issue with my inner ear.You are planning to receive a specific type of cochlear implant with certain electrodes.
Research Study Groups:
This trial has the following groups:- Group 1: Visual assessment of electrode insertion
- Group 2: Camera assessment of electrode insertion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cochlear Hearing Loss Patient Testimony for trial: Trial Name: NCT03101917 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this research project open for enrollment?
"This clinical trial seeks 12 individuals with auditory impairments and cochlear damage, aged 22 to 80. To be admitted into the study, these criteria must all apply."
Answered by AI
Is it possible for those under 30 to participate in this medical research?
"This trial is only available to those aged 22-80. For minors and senior citizens, there are 51 studies for patients under 18 years old, and 124 clinical trials designed specifically for elderly individuals over 65."
Answered by AI
Are the doors open for participants to join this experiment?
"Clinicaltrials.gov confirms that the initial post for this medical trial, which was uploaded on July 1st 2022 and last edited on May 12th of the same year, is no longer accepting applicants. However, 158 other clinical trials are still open to patient enrollment at present time."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Ohio
How old are they?
18 - 65
65+
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How soon will I be contacted for any additional information or advised if I meet the criteria?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
For a hopeful increased hearing ability.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Vanderbilt University Medical Center: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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