Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment (IOM laser)

August 17, 2017 updated by: Hospices Civils de Lyon

Pilot Study Evaluating Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment

The aging of the population, and greater exposure to noise, are responsible for an increased incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that has become a real public health problem. The main means of rehabilitation of this disability is represented by the apparatus of patients with conventional hearing aids. However, these hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis by the patient.

Middle ear implants were developed to answer these problems. They are intended to amplify the sound signal by transmitting directly to the middle ear to compensate for the hearing loss and are indicated in case of failure or contraindication of conventional equipment. However, these middle ear implants currently have limitations as performance failure. Recent data show that the performance of the ossicles repair techniques are dependent on the coupling of the ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the biomechanics of the ossicles confirm the importance of the placement and linkage of surgical restoration processes. This data can be applied to middle ear implants to improve performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of the vibration of the middle ear structures by laser velocimetry, allowed the investigators to define the transducer placement method and coupling method to ossicles.

Investigators wish to validate in vivo results in a pilot study on a small number of patients by comparing two surgical techniques guided by velocimetric measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 to 60 years;
  • Having given written informed consent prior to any procedure related to the study;
  • Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
  • Indication and IOM implantation request by the patient with a patient physically, psychologically and legally able to ask its implementation
  • Average deafness to severe (mean thresholds between 40 to 90 dB) with speech discrimination> 40% to 75 dB.
  • Deafness of pure perception or mixed hearing loss
  • Non-fluctuating deafness over the last two years
  • Failed or cons-indication to conventional equipment
  • Rocky Scanner and MRI normal brain
  • Patient fluent in French (to ensure validity audiological measures

Exclusion Criteria:

  • Pregnant women or likely to be during the study.
  • Not affiliated with a social security scheme Patients
  • Major Patients protected by provisions of the law (Public Health Code).
  • Refusal of consent.
  • Ongoing Participation in another study that may interfere with the proposed study (investigator assessment).
  • Existence of a cons-indication for surgery or port of the implant
  • Motivation only aesthetic, evaluated by the principal investigator.
  • Inability of predictable medium-term monitoring.
  • Acoustic neuroma, tumors and other evolutionary processes of the rock and the cerebellopontine angle.
  • Pathology requiring follow-up MRI (IOM against-indicating MRI).
  • Patient with against-indication to MRI.
  • Contraindication to the establishment of a pacemaker ossicular MET

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: control
standard care : usual technique for implanting
Device: Conventional implantation

Usual implantation technique of a middle ear implant. The principle of the ossicular stimulator middle ear transducer MET 7000 (Middle Ear Transducer, METTM) is to directly transmit sounds on the ossicles bypassing the outer ear. Their constraint is the surgical placement of the implant.

MET 7000 system (OTOLOGICS LLC, USA) is the implant that the investigators will use for their patients. The stimulator is usually placed against the body of the anvil by simple contact in the case of sensorineural hearing loss. In the case of mixed hearing loss, the stimulator will come in contact with the bracket using a titanium clip (ossicular prosthesis used in otologic surgery for ossiculoplasties). The optimized version corresponds to the use of the conventionally used in mixed deafness and applied to neurosensory deafness art. It is screwed onto the mastoid bone, the motor is suspended in the mastoid cavity and transmits vibrations to the body of the anvil by simple contact of the transducer.
Experimental: laser velocimetry
optimized implantation of laser velocimetry
Device: optimized implantation with laser velocimetry
Other Names:
  • Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC")

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
Time Frame: at baseline (day 0) and 8 months
The hearing will be measured by tone and speech audiometry in silence and in noise (dB) Results will be averaged per patient.
at baseline (day 0) and 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of surgical implantation performed for the surgical laser velocimetry optimization technique
Time Frame: at 14 months
number of surgical implantations performed in the required conditions and, if necessary, deviations will be described.
at 14 months
description of adverse events throughout the study
Time Frame: pre and post-operatively at day 0, at day 4, day 8 and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
pre and post-operatively at day 0, at day 4, day 8 and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Middle ear transfer function measured by laser velocimetry
Time Frame: pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
measured in mm/s/Pa
pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
Tone and speech audiometry in silence and in noise (dB)
Time Frame: Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score
Time Frame: day 0, and 2, 3, 5, 8 and 14 months.
Changes will be described in both groups. GHSI questionnaire appreciate the impact of hearing loss on quality of life and whose translation is adapted to the French context.
day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score
Time Frame: day 0, and 2, 3, 5, 8 and 14 months.
Changes will be described in both groups. GBI questionnaire appreciate the benefit of the port of hearing aid before surgery and the benefit of the middle ear implant after the surgery.
day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score
Time Frame: day 0, and 2, 3, 5, 8 and 14 months.
Changes will be described in both groups. APHAB questionnaire is validated in subjects deaf to assess the discomfort associated with deafness in conditions of erveday life.
day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score
Time Frame: day 0, and 2, 3, 5, 8 and 14 months.
Changes will be described in both groups. SSQ questionnaire evaluate the binaural hearing.
day 0, and 2, 3, 5, 8 and 14 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011.679

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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