NCT00030043

Brief Summary

This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2002

First QC Date

January 30, 2002

Last Update Submit

March 24, 2015

Conditions

Neurofibromatosis 2

Keywords

Electric StimulationImplants, ArtificialBrainstemElectrodesSpeech Perception

Interventions

Penetrating auditory brainstem implantDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of neurofibromatosis type 2
  • Speak English as a primary language

You may not qualify if:

  • Physical, psychological, or medical conditions that contraindicate the surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

House Ear Institute

Los Angeles, California, 90057, United States

Location

Huntington Medical Research Institutes

Pasadena, California, United States

Location

Cochlear Corporation

Englewood, Colorado, 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
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

January 30, 2002

First Posted

January 31, 2002

Study Start

September 1, 2001

Study Completion

August 1, 2003

Last Updated

March 25, 2015

Record last verified: 2002-01

Locations

US(3)