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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)

17. august 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: control
standard care : usual technique for implanting
Enhed: 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.
Eksperimentel: laser velocimetry
optimized implantation of laser velocimetry
Enhed: optimized implantation with laser velocimetry
Andre navne:
  • Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC")

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of surgical implantation performed for the surgical laser velocimetry optimization technique
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospices Civils de Lyon

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

20. juli 2016

Først indsendt, der opfyldte QC-kriterier

22. juli 2016

Først opslået (Skøn)

27. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2017

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011.679

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