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Набор скоро начнётся NCT07338864

A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults

— Наблюдательное Hearing Loss Hearing Implants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012).
Кому может быть актуально
Состояния в реестре: Hearing Loss, Hearing Implants. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Официальное название

A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation

Обзор

The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.

Вмешательства

  • Устройство Cochlear Nucleus Nexa Cochlear implant (CI1032)
    Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
  • Устройство Cochlear Nucleus Nexa Cochlear implant (CI1022)
    Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
  • Устройство Cochlear Nucleus Nexa Cochlear implant (CI1012)
    Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician

Первичные конечные точки

  • Mean within-participant change in the word recognition score in quiet [Срок оценки: Preimplantation to 6 months post-activation]
Вторичные конечные точки (5)
  • Incidence of adverse events and device deficiencies [Срок оценки: From enrolment to 12 months post-activation]
  • Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12) [Срок оценки: Preimplantation to 3, 6 and 12 months post-activation]
  • Mean within-participant change in word recognition score in quiet [Срок оценки: Preimplantation to 3 and 12 months post-activation.]
  • Mean within-participant change in Living with Cochlear implants questionnaire (LivCI) [Срок оценки: Preimplantation to 3, 6 and 12 months post-activation]
  • Mean within-subject change in speech recognition threshold in noise [Срок оценки: 3, 6 and 12 months post-activation]

Критерии участия

Критерии включения

  • Aged 18 years or older (at time of consent).
  • Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.
  • Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.
  • Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.
  • Candidate is a fluent speaker in the language used to assess speech perception performance.
  • Willing and able to comply with study follow-up schedule.
  • Willing and able to provide written informed consent.
  • Candidate has access to a Smartphone compatible with Nucleus Smart App.

Критерии исключения

  • Prior cochlear implantation in the ear to be implanted.
  • Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.
  • Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child or sibling.
  • Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
  • Women who are pregnant.
  • Current participation, or participation in an interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • University Hospital Düsseldorf — Düsseldorf

Идентификаторы

NCT: NCT07338864 · CLTD5819

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗