Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02589912
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-12-06
First Post:
2015-10-27
Brief Title:
Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients
Sponsor:
Massachusetts Eye and Ear Infirmary
Organization:
Massachusetts Eye and Ear Infirmary
Study Overview
Official Title:
Compassionate Use Arm - ABI541 Auditory Brainstem Implant for Neurofibromatosis Type 2 Patients With Deafness
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Nucleus 24 Auditory Brainstem Implant ABI is the only FDA approved device for restoration of meaningful hearing in Neurofibromatosis Type 2 NF2 patients This device has been discontinued meaning that there is no commercially approved device currently available The replacement model the ABI541 an unapproved device is being investigated in ongoing clinical trials A compassionate use arm of a clinical trial allows patients with NF2 to be implanted with this new ABI
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None