An Open Labeled Clinical Trial of Medical Device, for Diagnosis and Classification of Pleural Diseases Using Ultrasound Channel Data, While Minimizing Sampling Rate and Data Volume

Background and rationale:

The Pleura is a double-layered membrane surrounding the lungs. It is anatomically divided into Visceral Pleura, which is attached to the outer part of the lungs, and to the Parietal Pleura, which is attached to the inner side of the rib cage. Pathological processes involving the Pleura are incorporated under the name "Pleural diseases" which include, among others, pneumothorax, pleural effusion, and various tumors. This disease group is relatively widespread, and as evidence that the incidence reported in the literature is over 300 to 100,000 people in one year.

Diagnosis and evaluation of pleural disease involve the use of various neuroimaging devices such as chest radiographs, ultrasound, CT, and MRI. Most often, chest radiographs are widely accepted as the first means of identifying pleural diseases, with ultrasound, CT, and MRI supplementing or constituting a diagnostic confirmation if necessary.

Over the past few years, a significant perceptual change has been made in the use of chest ultrasound to diagnose pleural diseases as part of emergent and none emergent situations. Ultrasound has been shown to be an excellent imaging device for the assessment of pleural diseases. It is used as an auxiliary in a variety of clinical situations, such as pneumothorax detection in emergency situations, characterization of pleural fluid as simple or complex, the distinction between pleura thickening and pleural fluid loculations, and more. In addition to the diagnostic aspect, the ultrasound serves as a means of performing invasive operations in the chest. The use of ultrasound imaging for the chest is increasing, resulting in a significant increase in the quality of the diagnosis and a decrease in the incidence of various complications.

The ultrasound test uses sound waves to characterize various organ structure and function in health and disease. The test does not involve the use of ionizing radiation, so its use is safer than other techniques such as chest x-rays or CT examinations. The acquired and viewed images in the ultrasound device are real-time, so that changes can be detected and evaluated, which in many cases affects the final diagnosis. The test is non-invasive and does not require the use of contrast material containing substances that may cause an allergic reaction or impairment of kidney function. In addition, the instrumentation is more readily available for use at bedside examinations, and most tests do not require special preparations except for up to 6 hours of fasting in some cases.