A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02102256|
Recruitment Status : Recruiting
First Posted : April 2, 2014
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Profound Bilateral Deafness Due to Bilateral Cochlear Aplasia Bilateral Cochlear Nerve Deficiency Bilateral Cochlear Ossification Secondary to Meningitis||Device: Auditory Brainstem Implant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||November 2019|
Device: Auditory Brainstem Implant
Other Name: Cochlear Corporation Nucleus 24
- Primary endpoint [ Time Frame: 12-months post-device activation ]Serious adverse event (count) per subject. Count of expected serious adverse events per subject.
- Secondary endpoint: Preliminary efficacy [ Time Frame: 3 years post-device activation ]Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech.
- Unexpected Serious Adverse Events [ Time Frame: 12-months post-activation ]Unexpected adverse events (count).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102256
|Contact: Amy Martinez, MSemail@example.com|
|Contact: Laurie Eisenberg, PhDfirstname.lastname@example.org|
|United States, California|
|Keck School of Medicine of USC||Recruiting|
|Los Angeles, California, United States, 90008|
|Contact: Amy Martinez, MS 213-764-2807 email@example.com|
|Principal Investigator: Laurie Eisenberg, PhD|
|Children's Hospital Los Angeles||Active, not recruiting|
|Los Angeles, California, United States|
|Principal Investigator:||Laurie S. Eisenberg, PhD||Keck School of Medicine of USC|
|Principal Investigator:||Eric Wilkinson, MD||Huntington Medical Research Institute|