Cochlear ImplantsLOTOSNCT06343571
Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Implants
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 17 Apr 2024to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- MED-EL CI recipients
- FLEX electrode array
Who cannot join
- Lack of compliance with any inclusion criterion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode Array: a Retrospective Study
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.
- Conditions
- Cochlear Implants
- Keywords
- cochlear implants
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion: single data extraction (3 month to completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start17 Apr 2024
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Büchner, Prof, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343571
- Sponsor's protocol ID
- MED-EL_CRD_2022_12
- Acronym
- LOTOS
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode Array: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06343571
- Acronym / sponsor ID
- LOTOS / MED-EL_CRD_2022_12
- Conditions
- Cochlear Implants
- Keywords
- cochlear implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (2 listed)
- MED-EL CI recipients
- FLEX electrode array
Key exclusion criteria (1 listed)
- Lack of compliance with any inclusion criterion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety.
Time frame: Through study completion: single data extraction (3 month to completion)
Longitudinal data from clinical routine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Büchner, Prof principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety. (time frame: Through study completion: single data extraction (3 month to completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.