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Набор скоро начнётся NCT07018882

Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.

Без фазы С лечением Hearing Loss, Sensorineural

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: Sullivan.
Кому может быть актуально
Состояния в реестре: Hearing Loss, Sensorineural. Базовые параметры: от 19 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Single-Center, Single-arm, Open, Prospective, Pivotal Clinical Trial for Evaluating the Audiological Efficacy and Safety of Sullivan Cochlear Implantation in Patients With Severe to Profound Bilateral Hearing Loss.

Обзор

The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study

Подробное описание

This study is a clinical trial designed to examine the auditory performance improvement in patients with bilateral severe sensorineural hearing loss (70 dB HL or greater) by comparing auditory performance before and after cochlear implant surgery.

Cochlear implants, both imported and domestically manufactured, have already been approved and are in use in the country. These existing devices have also undergone clinical research, comparing and analyzing auditory performance before and after implantation. Therefore, this study is designed as a prospective, single-arm, open-label clinical trial.

Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments.

Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Вмешательства

  • Устройство Sullivan
    Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments. Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Первичные конечные точки

  • Change in open-set sentence recognition [Срок оценки: at 12-week and 24-week post-implant]
Вторичные конечные точки (3)
  • Change in open-set monosyllabic word recognition [Срок оценки: at the 12-week and 24-week post-implant]
  • Change in open-set bisyllabic word recognition [Срок оценки: at the 12-week and 24-week post-implant]
  • Change in pure-tone hearing thresholds [Срок оценки: at the 12-week and 24-week post implant]

Критерии участия

Критерии включения

  • Patients with sensorineural hearing loss of 1 side or both sides (70 dBHL) or higher, aged 19 years or older
  • No previous cochlear implantation history in the ear scheduled for surgery
  • No contraindications to surgery, such as cochlear agenesis or auditory nerve agenesis, as determined by imaging tests
  • Patients without cancer, autoimmune disease, or neurological disease
  • Patients with a general condition that allows general anesthesia
  • Patients with no abnormalities in personality, depression, anxiety, sociality, or problem drinking tests
  • Use Korean
  • Patients who agree to participate in the clinical trial and sign a written consent form However, if the patient is unable to sign, the patient (if able to sign) and guardian (or agent) voluntarily agree to participate in the clinical trial and sign an informed consent form

Критерии исключения

  • Cases where electrode insertion is difficult due to severe internal malformation, cochlear ossification, etc.
  • Cases with cancer or autoimmune disease
  • Cases with a general condition that makes it difficult to tolerate general anesthesia
  • Cases with moderate or higher mental disability or where auditory training is difficult due to the absence of parents or supporters to assist with rehabilitation education
  • Cases deemed inappropriate for this test by the clinical trial manager

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07018882 · Sullivan

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗