Auditory Intranerve Stimulation Study | NCT06306534

Studies
Auditory Intranerve Stimulation Study

NCT06306534

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Jan 15, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Auditory; Nerve

Interventions

Auditory Nerve Acute (ANA) Electrode Array

Countries

Germany

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

ID	Type	Description	Link
CIV-22-05-039592	Other Grant/Funding Number	Blackrock Neurotech

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

Mar 15, 2025Estimated

Completion Date

Mar 15, 2025Estimated

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 12, 2024Actual

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

Jan 13, 2025

Last Update Posted Date

Jan 15, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insert Array Into Auditory Nerve	Experimental		Other: Auditory Nerve Acute (ANA) Electrode Array

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auditory Nerve Acute (ANA) Electrode Array	Other	To measure eABRs when stimulating the human auditory nerve	Insert Array Into Auditory Nerve

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Collection of adverse events		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
Age ≥ 18 years
Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

Exclusion Criteria:

Disabilities in addition to hearing impairment which might interfere with the study procedure
Pregnant and breast feeding woman or other vulnerable population

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

Name	Role	Phone	Extension	Email
Karl-Heinz Dyballa	Contact	+4917615328589		dyballa.karl-heinz@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Thomas Lenarz, Prof. Prof. Dr.	Hannover Medical School, Director of otorhinolaryngology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School	Recruiting	Hanover		30625	Germany

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
D000160	Vestibulocochlear Nerve Diseases

Ancestor Terms

ID	Term
D012181	Retrocochlear Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D003389	Cranial Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided