Longitudinal Outcomes in MED-EL Cochlear Implant Recipien... | NCT06343571

Studies
Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode

NCT06343571

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Cochlear Implants

Interventions

Not provided

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

Status Module

Record Verification Date

Sep 2024

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 17, 2024Actual

Primary Completion Date

Aug 26, 2024Actual

Completion Date

Aug 26, 2024Actual

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Apr 2, 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

Sep 10, 2024

Last Update Posted Date

Sep 19, 2024Actual

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

This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety.	Longitudinal data from clinical routine	Through study completion: single data extraction (3 month to completion)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MED-EL CI recipients
FLEX electrode array

Exclusion Criteria:

Lack of compliance with any inclusion criterion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

There is no requirement to actively participate in the study for any of the subjects.

This study consists of a one-time data extraction from a clinical database. Data will be included from 03/2006 to date of extraction

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Büchner, Prof	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School		Hanover			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