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Revision Surgery for Cochlear Implant Tissue Growth
N/A
Waitlist Available
Led By Jack Noble, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female 18 years of age and above undergoing revision cochlear implant surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
Study Summary
This trial is designed to study whether a computational model can accurately predict the presence of scar tissue growth around the implanted electrode array in patients who have had a cochlear implant for at least one year.
Who is the study for?
This trial is for adults over the age of 18 who are already using cochlear implants and need to have revision surgery. It's not open to anyone under 18 or those who aren't scheduled for this type of surgery.Check my eligibility
What is being tested?
The study tests a new way to use CT images and device measurements to simulate how cochlear implants work in the ear, especially when scar tissue forms around them. The goal is to see if these simulations can help improve implant programming by predicting tissue growth.See study design
What are the potential side effects?
Since participants are already undergoing revision surgery, additional side effects specifically from the trial are minimal. However, typical risks associated with cochlear implant surgeries may include infection, bleeding, or damage to nearby structures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and need another cochlear implant surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tissue growth
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
The single observational cohort
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,168 Total Patients Enrolled
Robert Labadie, MD,PhDStudy ChairVanderbilt University Medical Center
Jack Noble, PhDPrincipal InvestigatorVanderbilt University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old or I am not having repeat cochlear implant surgery.I am 18 or older and need another cochlear implant surgery.
Research Study Groups:
This trial has the following groups:- Group 1: 1
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have recruitment opportunities opened up for this research yet?
"Data found on the clinicaltrials.gov website suggests that this trial is no longer seeking participants, as it was initially posted in February 15th 2023 and last updated on October 25 2022. Nevertheless, there are presently fifteen other trials actively recruiting patients."
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