NCT06343571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

April 17, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

March 13, 2024

Last Update Submit

September 10, 2024

Conditions

Cochlear Implants

Keywords

cochlear implants

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • MED-EL CI recipients
  • FLEX electrode array

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Germany

Location

Study Officials

  • Andreas Büchner, Prof

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

April 2, 2024

Study Start

April 17, 2024

Primary Completion

August 26, 2024

Study Completion

August 26, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)