Auditory Nerve Monitoring Using Intra-cochlear Stimulatio... | NCT02948790

Studies
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma

NCT02948790

Sponsor

Oticon Medical

Status

Completed

Last Update Posted

Oct 20, 2021Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Hearing Loss, Cochlear
Neurinoma of the Acoustic Nerve

Interventions

Neuristim
Cochlear implant

Countries

France

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2017Actual

Primary Completion Date

Apr 3, 2019Actual

Completion Date

Apr 3, 2019Actual

First Submitted Date

Oct 26, 2016

First Submission Date that Met QC Criteria

Oct 27, 2016

First Posted Date

Oct 28, 2016Estimated

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

Oct 13, 2021

Last Update Posted Date

Oct 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.

Detailed Description

Whatever the acoustic neuroma treatments, the patient risks a hearing loss. The global strategy of hearing care aims to preserve the quality of life and patient hearing. For severe to profound hearing loss and anatomical auditory nerve preservation, the cochlear implant is put forward compared to the auditory brainstem implant. Indeed, cochlear implant provides better speech outcomes. If cochlear implantation is not possible or no benefit for the patient, the brainstem implant is the most widely used. The Neuristim device is used to investigate the auditory nerve integrity following neuroma surgery or on an affected auditory nerve. The Neuristim is an intra-cochlear stimulator used in an intraoperative way. The intra-cochlear electrodes provide an electrical stimulation to auditory nerve fibers, and auditory nerve response measurements to these electrical stimulation are recorded and evaluated to determine the auditory nerve functionality. The Neuristim is a device for helping surgeons to choose the most appropriate implantable solution. 2 groups of patients will be involved in this study:

a group of 17 patients with an acoustic neuroma or a past neuroma surgically removed or acoustic neuroma not requiring a surgery and with severe to profound hearing loss candidate for a cochlear implant or a auditory brainstem depending on the auditory nerve functionality,
a group of 17 patients with severe to profound hearing loss candidate for a cochlear implant.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuristim	Experimental	Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).	Device: Neuristim
Digisonic SP EVO cochlear implant	Active Comparator	Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).	Device: Cochlear implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuristim	Device	Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode	Neuristim

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wave V latency		perioperatively

Secondary Outcomes

Measure	Description	Time Frame
Complications		perioperatively, 15 days postoperatively
Impedance measurement		perioperatively
ergonomics of the Neuristim

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be 18 years or older
Patient with an acoustic neuroma already surgically removed with associated hearing loss (experimental group),
Patient with an acoustic neuroma programmed to be surgically removed and candidates for an implantable hearing rehabilitation solution (experimental group),
Patient with an acoustic neuroma that not need to be removed and candidate for an implantable hearing rehabilitation solution (experimental group), or
Typical patient candidate for a cochlear implant (control group)

Exclusion Criteria:

Cochlea malformation, cochlea ossification
Vulnerable subject

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe Vincent, MD	Hospital University Lille-Roger Salengro	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bordeaux - Pellegrin		Bordeaux			France
University Hospital Grenoble - A. Michallon

Label	URL
oticon medical website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006319	Hearing Loss, Sensorineural
D009464	Neuroma, Acoustic

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003054	Cochlear Implants

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided