NCT02589912

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

First QC Date

October 27, 2015

Last Update Submit

December 4, 2019

Conditions

Neurofibromatosis Type 2Severe Profound Sensorineural Hearing Loss

Interventions

Nucleus Profile ABI541 Auditory Brainstem ImplantDEVICE

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 2

Condition Hierarchy (Ancestors)

Neuroma, AcousticNeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeurofibromatosesNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeuromaNeoplastic Syndromes, HereditaryVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve NeoplasmsCranial Nerve DiseasesNervous System DiseasesNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations

US(1)