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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Ultrasound data
Study Overview
Brief Summary
Background:
The Pleura is a double-layered membrane that surrounds the lungs. Pathological processes that involve the Pleura are called "Pleural diseases". Among them are included Pneumothorax (Air the chest cavity), Pleural effusions, and tumor formation.
Ultrasound imaging of the Pleura to detect and assess pleural diseases has been proven as an excellent diagnostic and safe option. Ultrasound test uses sound waves to characterize the structure and function of different organs in health and disease.
The standard technique used to create two-dimensional ultrasound picture is called Delay and Sum (DAS). Signals are transmitted and received from a series of elements and allow a two dimensional picture to be created. Because a large number of sensors is required, creating a two dimensional picture creates a large and usually redundant data pool.
This fact leads to a need for stronger processors and larger operating systems, Consumption of higher energy, and hence an ungainly, slow, and expensive system.
Signal Acquisition Modeling and Processing Laboratory (SAMPLE) in Weizmann institute has developed a data processing system that allows narrowing down the number of elements needed to process the ultrasound signal, while creating an ultrasound picture of abdominal organs in a satisfying resolution. Sometimes even better than standard methods.
Research goal:
Improvement of diagnosis and characterization of pleural diseases by Ultrasound, using a novel algorithm that was developed in SAMPLE laboratory in Weizmann Institute. The aim is to create a faster, more reliable ultrasound imaging while minimizing sampling rate and data volume.
Methods:
Tested population: Women and/or men who were diagnosed with Pneumothorax or Plural effusion with other imaging modalities, and healthy volunteers as a control group, Up to 30 participants per each group (Total up to 90), in a 1:1:1 Ratio.
Research type:
An open-labeled study.
Experimental design:
Participants that will meet the required conditions will be summoned to an exam in our imaging institute or will be scanned bedside, using the Verasonics ultrasound system, which allows free access to ultrasound raw Channel data. The information acquired, as well as other imaging scans of the participant, will be coded and delivered anonymously to SAMPLE laboratory for analysis.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers
- •Volunteers with active Pneumothorax, detected by prior imaging studies up to 24 hours before the ultrasound scan
- •Volunteers with active Pleural effusion, detected by prior imaging studies up to 48 hours before the ultrasound scan ult
Exclusion Criteria
- •Volunteers with the aforementioned diagnosis, which was not detected during the actual ultrasound exam
- •Volunteers who expressed their desire to be excluded from the study at any given time point.
Outcomes
Primary Outcomes
Ultrasound data
Time Frame: 1 year
Detection of pneumothorax or pleural effusion will be documented and assessed for the following parameters: Pneumothorax: 1. The presence of "lung sliding sign" in B bode. 2. The presence of "Comet tail artifacts" in B mode. 3. The "Barcode sign" mark in M mode. Pleural effusion: 1. Quantity of fluid according to acceptable clinical assessment: no fluid, minimal, medium, or large fluid. 2. Effusion characteristics by evaluation of Echogenicity, Homogenicity, presence of septations and loculations.
Secondary Outcomes
No secondary outcomes reported
Investigators
Israel Aharoni
Radiology resident, HaEmek Medical Center Radiology institute, Principal investigator.
HaEmek Medical Center, Israel