- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02589912
Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients
Compassionate Use Arm - ABI541 Auditory Brainstem Implant for Neurofibromatosis Type 2 Patients With Deafness
Study Overview
Status
Intervention / Treatment
Detailed Description
Currently, the Nucleus 24 (ABI24M) Auditory Brainstem Implant (ABI) is approved for use in individuals 12 years of age or older who have been diagnosed with Neurofibromatosis Type 2 (NF2). Implantation may occur during first or second side tumor removal or in patients with previously removed vestibular schwannomas bilaterally. As the ABI24M is now obsolete, there is currently no commercially approved device available to restore useful hearing in patients. While the manufacturer of the device is pursuing commercial approval of the ABI541, it is anticipated that it may be several months or years before final approval. However, it is preferable to place the device at the time of tumor removal while the patient has an open craniotomy site, thereby avoiding a second surgery and its associated risks solely for the purpose device implantation. In addition, placement of an ABI at the time of tumor removal optimizes auditory rehabilitation, providing critical auditory sensations that may more effectively maintain auditory pathways. The FDA approved a compassionate use arm for an ongoing clinical trial to permit implantation of the ABI541 in up to 10 NF2 patients.
Patients will undergo pre-operative evaluation for ABI surgery. Those who are appropriate for surgery will undergo a procedure for implantation of the ABI541. As per manufacturer protocol, the parameters of the ABI541 including adjustment of electrode sensitivities and activation of specific electrodes will be completed at each follow-up visit post-operatively. This process involves adjustment of device parameters by a trained audiologist who subsequently administers audiologic tests to confirm optimal activation of the ABI541.
All audiologic testing and assessments represent the standard of care. These post-operative follow-up appointments will occur at 4-12 weeks, three, six, and twelve months, and biannually thereafter. Timing of these appointments may vary by as much as four weeks prior to or after the planned follow-up date (e.g. between 2-4 months for the 3 month follow-up). Unscheduled visits will be taken in the Otology clinic as needed to address any concerns patients may have regarding the use of their Nucleus ABI541.
Study Type
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Neurofibromatosis Type 2;
- Age of 12 years or older
- Will be anticipated to be completely deaf as a result of bilateral neurofibromas of the auditory nerve, and/or their surgical removal.
Exclusion Criteria:
- Contraindications to surgery or general anesthesia
- Intractable seizures or progressive, deteriorating neurological disorder
- Unable to participate in behavioral testing and mapping with ABI
- Unrealistic expectations on the part of the subject/family regarding possible benefits, risks, and limitations that are inherent to the procedure and prosthetic device
Study Plan
How is the study designed?
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neurodegenerative Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Ear Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Cranial Nerve Diseases
- Sensation Disorders
- Neuroendocrine Tumors
- Hearing Disorders
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neuroma, Acoustic
- Neurilemmoma
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Hearing Loss
- Hearing Loss, Sensorineural
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibroma
- Neurofibromatosis 2
Other Study ID Numbers
- 15-113H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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