NCT06360926终止不适用
Improvement Image Quality for SuperSonic® MACH Ultrasound System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Qualitative assessment of image quality
研究概览
简要总结
The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe).
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is ≥ 18 years old and is able to understand and sign the informed consent form.
- •Subject is a minor < 18 years old and the legal representative has signed the informed consent form.
- •Subject is scheduled for at least one or more routine ultrasounds.
- •Subject is affiliated to National Social Insurance or a Health Insurance Regimen.
排除标准
- •Subject is unable or unwilling to adhere to Study procedures.
- •Subject or his/her legal representative if a minor is unable to express or understand informed consent.
- •Subject is under legal protection
- •Subject is deprived of liberty by judicial or administrative decision
- •Subject undergoes psychiatric treatment under constraint
- •Subject is admitted to a health or social establishment for purposes other than research
- •Subject has latex allergy.
- •Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
结局指标
主要结局
Qualitative assessment of image quality
时间窗: During ultrasound procedure
Following the two ultrasound procedures, the radiologist will rate the image quality produced by the Study Device, compared to that produced by the SOC ultrasound. A score from 1 to 5 (1: Not acceptable; 2: Acceptable; 3: Fair; 4: Good; 5: Excellent) for each of the characteristics of the image: General Aesthetics; Spatial Resolution; Contrast Resolution; Temporal Resolution; Penetration and Sensitivity
次要结局
未报告次要终点
研究者
研究点 (2)
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