Идёт набор NCT06097845

Transcranial Ultrasound Via Sonolucent Cranioplasty

Без фазы С лечением Cranioplasty Sonolucent Cranioplasty Reconstructive Cranioplasty

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: Transcranial Ultrasound.
Кому может быть актуально: Состояния в реестре: Cranioplasty, Sonolucent Cranioplasty, Reconstructive Cranioplasty. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.

Подробное описание

Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI \& CT) in a prospective, quality control study.

Вмешательства

Диагностический тест Transcranial Ultrasound
Patients who underwent reconstructive sonolucent cranioplasty will receive standard of care postoperative imaging (i.e. CT, MRI) in addition to ultrasound imaging. Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices (GE Venue Go, Fujifilm Sonosite X-Porte, GE Volusion E10 and Clarius HD3 etc.) currently used in routine clinical practice.

Первичные конечные точки

Identification of Neuroanatomy accuracy of TCUS [Срок оценки: 12 months]
Diagnostic accuracy of TCUS [Срок оценки: 12 months]

Критерии участия

Критерии включения

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.
Male or female, aged ≥ 18.