Feasibility Study of Auditory Brainstem Implant in Young... | NCT01850225

Studies
Feasibility Study of Auditory Brainstem Implant in Young Children

NCT01850225

Sponsor

House Research Institute

Status

Withdrawn

Last Update Posted

Mar 18, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Bilateral Cochlear Aplasia
Bilateral Cochlear Nerve Deficiency
Bilateral Cochlear Ossification Secondary to Meningitis

Interventions

Auditory brainstem implant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Apr 24, 2013

First Submission Date that Met QC Criteria

May 8, 2013

First Posted Date

May 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Name	Class
House Clinic, Inc.	INDUSTRY
Children's Hospital Los Angeles	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device implantation	Experimental	Implantation of device	Device: Auditory brainstem implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auditory brainstem implant	Device		Device implantation	Cochlear Corporation Nucleus 24

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Serious Adverse Events	Count of the number of expected serious adverse events must not exceed that known to occur in pediatric retrosigmoid craniotomy and Count of the number of unexpected serious adverse events must not exceed 2 in the first 5 children.	12-month post-activation

Secondary Outcomes

Measure	Description	Time Frame
Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech	ability to detect sounds	3 years post-activation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
If previously received a cochlear implant, must demonstrate lack of benefit from that device

Exclusion Criteria:

Medical contraindication to craniotomy/intracranial surgery
Severe cognitive or developmental delays

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Wilkinson, MD	House Research Institute	Principal Investigator
Laurie Eisenberg, PhD	House Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
House Research Institute CARE Center		Los Angeles	California	90057	United States

Intervention Browse Module

MeSH Terms

ID	Term
D038262	Auditory Brain Stem Implants

Ancestor Terms

ID	Term
D058117	Neural Prostheses
D058542	Implantable Neurostimulators
D004567	Electrodes, Implanted
D004566	Electrodes

Browse Leaves

Not provided

Browse Branches

Not provided