Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part II: Detection of Pyelocaliceal Dilation and Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Presence of Pyelocaliceal dilation
研究概览
简要总结
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.
This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.
The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.
The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.
详细描述
The echOpen device includes an ultrasound probe and a mobile application. The mechanical probe emits at three ultrasound frequencies, 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, which allows the exploration of the interior of the body at different depths in a non-invasive and non-irradiating manner.
Thus, the purpose of the echOpen device is, on one hand, to guide the diagnosis during the clinical examination and, on the other hand, to identify anatomical structures in order to assist in management.
The objective of the clinical investigation is to demonstrate that the echOpen device is able to identify semiological signs and localize anatomical structures at different depths of the body, with a performance not inferior to that of other ultrasound devices, routinely employed in hospital clinical departments.
The signs of interest (i.e. detection of pyelocaliceal dilation (3.5 Mhz) and hepatic steatosis (5.0 Mhz) were chosen for their clinical usefulness (their identification during the clinical examination constitutes an argument for orientation and/or severity) and for their prevalence in the study population.
An ultrasound probe in use in the hospital clinical departments where the investigation takes place will be employed as a comparator to judge the performance of the echOpen device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Adult patient (age ≥ 18 years old)
- •Patient having signed the informed consent to participate in this clinical investigation
- •Patient affiliated to the social security scheme
- •Patient arriving in the hospital clinical ward (own initiative or by emergency services) whose clinical symptomatology suggests the presence of pathological elements which would be visible using an ultrasound probe in the following cases:
- •Search for pyelocaliceal dilation: patient consulting for abdominal and/or lumbar pain and/or iliac fossa, fever, pain in the right or left iliac fossa, anuresis
- •Search for hepatic steatosis: in a case of global clinical examination, abnormal laboratory test results, known or suspected metabolic disease, any situation suggesting the presence of hepatic steatosis
排除标准
- •Minor patient (age < 18 years)
- •Patients under the State Medical Assistance (AME)
- •Obese patient (body mass index > 29.9)
- •Patient in too serious condition for the clinical examination to be done fully and/or with additional exploratory time
- •Unstable patient: need for immediate care, impossibility to carry out a thorough clinical examination including interview, palpation, auscultation, percussion
- •Known allergy to ultrasound gel
结局指标
主要结局
Presence of Pyelocaliceal dilation
时间窗: Day 0
Pyelocaliceal system assessment by using echOpen or a portable ultrasound routinely used in the department and scored as follows: 0, normal condition; 1, normal parenchyma, dilated renal pelvis, undilated calyces; 2, normal parenchyma, renal pelvis and calyces dilated, papillary impression preserved; 3, parenchyma thinned, significant pyelocaliceal dilation with bulging calyxes and disappearance of the papillary impression; 4, very thinned parenchyma, massive pyelocaliceal dilation, disappearance of the pyelocaliceal differentiation.
Presence of Hepatic steatosis
时间窗: Day 0
Hepatic steatosis assessment by using echOpen or a portable ultrasound routinely used in the department and scored on the base of liver echogenicity as follows: 0, normal condition; 1, local hyperechogenicity; 2, diffuse hyperechogenicity
次要结局
- Hepatic steatosis determined using a gold standard procedure(Day 0)
- Pyelocaliceal dilation determined using a gold standard procedure(Day 0)