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Auditory Nerve Test System for Acoustic Neuroma (ANTS Trial)
N/A
Waitlist Available
Led By Cameron C Wick, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial cochlear implant activation, then repeated at 6-months and 12-months after activation.
Awards & highlights
ANTS Trial Summary
This trial is testing a new device that stimulates the auditory nerve, which may help patients with a vestibular schwannoma and hearing loss.
Who is the study for?
This trial is for individuals aged 12 or older with a vestibular schwannoma (a type of benign brain tumor) smaller than 2.5 cm, causing hearing loss. They should not have had previous ear implants, microsurgery, or radiation for the tumor and must be willing to follow the study's protocol.Check my eligibility
What is being tested?
The Auditory Nerve Test System (ANTS), a new device similar to a cochlear implant, is being tested during surgery to remove vestibular schwannomas. If successful, it could help preserve hearing by confirming nerve integrity before also fitting a cochlear implant.See study design
What are the potential side effects?
Potential side effects may include risks associated with surgical procedures such as infection or bleeding, possible damage to the auditory nerve despite testing, and general complications from receiving an implant like inflammation or device failure.
ANTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initial cochlear implant activation, then repeated at 6-months and 12-months after activation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial cochlear implant activation, then repeated at 6-months and 12-months after activation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Auditory Nerve Electrophysiology
Secondary outcome measures
Cochlear Implant Speech Performance
Quality of Life Following Vestibular Schwannoma Resection
Sound Localization
ANTS Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
Patients undergoing a translabyrinthine approach for vestibular schwannoma resection will have the health of their auditory nerve monitored during tumor dissection. If the auditory nerve is visually confirmed to be intact, then concurrent cochlear implantation will be performed.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,699 Total Patients Enrolled
Cameron C Wick, MDPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery or targeted radiation for this tumor before.You have not had a cochlear implant or auditory brainstem implant before.You have used a cochlear implant in one or both ears before.You have a type of tumor that is not a vestibular schwannoma.Your tumor is larger than 2.5 cm.You should have good hearing in the ear with the tumor.You have not had microsurgery or targeted radiation for this tumor before.Your doctor cannot see if your auditory nerve is working properly after removing a tumor.You have a type of brain tumor called vestibular schwannoma.Your tumor is smaller than 2.5 centimeters.You have hearing loss in one ear that cannot be improved with a hearing aid.You have realistic expectations about how well a cochlear implant will work for you.Your doctor has confirmed that your auditory nerve is working properly after removing a tumor.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
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.
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