Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
研究概览
简要总结
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
详细描述
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18-80 years of age
- •Subjects has provided informed consent
- •Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
- •Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
- •CBCT exam performed within a maximum of 2 days of the conventional CT.
排除标准
- •Subjects under the age of 18 years, or over the age of 80 years
- •Unable to collect all required case information
- •Subjects not willing to consent, or consent is withdrawn
- •Women in pregnancy or suspected of being pregnant confirmed by pregnancy test
研究组 & 干预措施
Investigational CBCT
Radiation
干预措施: Radiation (Radiation)
结局指标
主要结局
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
时间窗: 11 months
Percentage of Participants with \>=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients. Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes.
次要结局
未报告次要终点