Middle Ear Implant: Assessment of Satisfaction in the Med... | NCT04175275

Studies
Middle Ear Implant: Assessment of Satisfaction in the Medium Term

NCT04175275

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Nov 3, 2020Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Deafness

Interventions

Interview patient

Countries

France

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

Nov 2020

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

Mar 15, 2020Actual

Primary Completion Date

May 21, 2020Actual

Completion Date

May 21, 2020Actual

First Submitted Date

Nov 21, 2019

First Submission Date that Met QC Criteria

Nov 21, 2019

First Posted Date

Nov 25, 2019Actual

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

Nov 2, 2020

Last Update Posted Date

Nov 3, 2020Actual

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

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

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

70Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview patient	Other	Interview patient without scoring about the reasons for the implant, the complications, the reasons for abandonment, the evaluation of the satisfaction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the abandonment rate	calculate the rate of patient having abandonment the Use of Middle Ear Implant	at inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric TRUY, MD	Service de chirurgie ORL et cervico faciale	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Edouard Herriot		Lyon		69003	France

Condition Browse Module

MeSH Terms

ID	Term
D003638	Deafness

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided