NCT04175275

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

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

November 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 21, 2019

Last Update Submit

November 2, 2020

Conditions

Deafness

Outcome Measures

Primary Outcomes (1)

  • the abandonment rate

    calculate the rate of patient having abandonment the Use of Middle Ear Implant

    at inclusion

Interventions

Interview patientOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all living patients who have benefited from the placement of a middle ear implant since 1998 at Hospices Civils of Lyon.

You may qualify if:

  • Age ≥ 18 years
  • Patient accepting to participate to this study

You may not qualify if:

  • patient not dead

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Edouard Herriot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric TRUY, MD

    Service de chirurgie ORL et cervico faciale

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 25, 2019

Study Start

March 15, 2020

Primary Completion

May 21, 2020

Study Completion

May 21, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

FR(1)