Middle Ear Implant: Assessment of Satisfaction in the Medium Term

NCT ID: NCT04175275

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-15

Study Completion Date

2020-05-21

Brief Summary

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Currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years).

Based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.

Detailed Description

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Conditions

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Deafness

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Interview patient

Interview patient without scoring about the reasons for the implant, the complications, the reasons for abandonment, the evaluation of the satisfaction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patient accepting to participate to this study
* Patient having a middle ear implant since 10 - 20 years at time of inclusion

Exclusion Criteria

* patient not dead
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric TRUY, MD

Role: PRINCIPAL_INVESTIGATOR

Service de chirurgie ORL et cervico faciale

Locations

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Hopital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL19_0283

Identifier Type: -

Identifier Source: org_study_id