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临床试验/NCT06097845
NCT06097845招募中不适用

Transcranial Ultrasound Via Sonolucent Cranioplasty

Northwell Health1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Identification of Neuroanatomy accuracy of TCUS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 1. Patients who are pregnant

结局指标

主要结局

Identification of Neuroanatomy accuracy of TCUS

时间窗: 12 months

Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound

Diagnostic accuracy of TCUS

时间窗: 12 months

Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Netanel Ben-Shalom

Principal Investigator

Northwell Health

研究点 (1)

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