通过声光颅骨成形术进行经颅超声检查
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tamika Wong, MPH
- 电话号码：212-434-4836
- 邮箱：twong4@northwell.edu
研究联系人备份
- 姓名：Netanel Ben-Shalom, MD
- 电话号码：212-434-3900
- 邮箱：nbenshalom@northwell.edu
学习地点
-
-
New York
-
New York、New York、美国、10075
- 招聘中
- Lenox Hill Hospital
-
接触：
- Tamika Wong, MPH
- 电话号码：212-434-4836
- 邮箱：twong4@northwell.edu
-
副研究员：
- Tamika Wong, MPH
-
副研究员：
- Olivia Albers, NP
-
副研究员：
- Randy D'Amico, MD
-
副研究员：
- Vadim Zhigin, PA
-
接触：
- Netanel Ben-Shalom, MD
- 电话号码：212-434-3900
- 邮箱：nbenshalom@northwell.edu
-
副研究员：
- Heustein Sy, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Patients who are pregnant
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Transcranial Ultrasound
Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice. |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Identification of Neuroanatomy accuracy of TCUS
大体时间：12 months
|
Accuracy metrics related to identification and measurement of neuroanatomy structures using Trasncranial Ultrasound |
12 months
|
|
Diagnostic accuracy of TCUS
大体时间：12 months
|
Accuracy metrics related to detection of postoperative complications using Trasncranial Ultrasound |
12 months
|
合作者和调查者
调查人员
- 首席研究员：Netanel Ben-Shalom, MD、Lenox Hill Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 22-0873
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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