Neurofibromatosis Type 2NCT02589912
Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients
A study testing Nucleus Profile ABI541 Auditory Brainstem Implant in people with Neurofibromatosis Type 2 and Severe Profound Sensorineural Hearing Loss, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Neurofibromatosis Type 2, Severe Profound Sensorineural Hearing Loss
- What is being tested?
- Nucleus Profile ABI541 Auditory Brainstem Implant
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: Compassionate Use Arm - ABI541 Auditory Brainstem Implant for Neurofibromatosis Type 2 Patients With Deafness
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.
Read the 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.
- Being tested
- Nucleus Profile ABI541 Auditory Brainstem Implant
- Medical subject headings
- Neurofibromatosis 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleus Profile ABI541 Auditory Brainstem ImplantDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589912
- Sponsor's protocol ID
- 15-113H
- Status last verified
- Dec 2019
- First submitted
- 27 Oct 2015
- Last updated
- 6 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use Arm - ABI541 Auditory Brainstem Implant for Neurofibromatosis Type 2 Patients With Deafness
- ClinicalTrials.gov ID
- NCT02589912
- Acronym / sponsor ID
- 15-113H
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nucleus Profile ABI541 Auditory Brainstem Implant | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucleus Profile ABI541 Auditory Brainstem Implant in people with Neurofibromatosis Type 2 and Severe Profound Sensorineural Hearing Loss, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.