Diagnosis of Cardio-Pulmonary Pathology Using Transthoracic Parametric Doppler (TPD)

Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)

This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and the unique software the investigators have developed analyzes the signal reflected back from within the lung. On the basis of pilot studies performed previously the investigators expect to receive different signals from different diseases. The investigators seek to further characterize these signals to enable accurate diagnosis of different lung diseases using our technology.

Study Overview

• Status: Completed
• Conditions: Asthma; Hypertension, Pulmonary; Sarcoidosis; Lung Disease, Chronic Obstructive; Lung Disease, Interstitial

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3505331
    • Regional Pulmonary Clinic, Clalit Health Services
  • Haifa, Israel, 35053
    • Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to a large hospital-affiliated community lung clinic.

Description

INCLUSION CRITERIA

Age 18 years or older Patients who are clinically suspected of having pulmonary, cardiac or Cardio-pulmonary disease preferably any one or more of the conditions listed below:

• Patients with CHF
• Patients with pulmonary hypertension with documented right heart catheterization data

• Patients with COPD in two subgroups:

  • Emphysema, (evidence of emphysema on High Resolution Computed Tomography, (HRCT) and airflow limitation of GOLD II severity who have had Carbon Monoxide Diffusing capacity, (DLCO) and Residual Volume(RV) measured, or patients without HRCT with measurements of lung volumes and diffusing capacity with Total Lung Capacity (TLC) ≥1.0 predicted, RV/TLC ≥0.4, DLCO ≤ 0.7 predicted.
  • Chronic Bronchitis (No evidence of Emphysema on HRCT and/or no evidence of air-trapping or reduced DLCO.)
• Patients with asthma according to ATS/ERS definition,

• Patients with interstitial lung disease (ILD) of any etiology including sarcoidosis diagnosed by HRCT in sub groups as follows:

  • Mild ILD (TLC 0.71-0.79 predicted, DLCO ≥ 0.71 predicted)
  • Moderate and severe ILD (TLC ≤ 0.7 predicted, DLCO ≤ 0.7 predicted)
• Signed informed consent.
• Patients with sarcoidosis without evidence of parenchymal lung disease defined as normal DLCO and/or HRCT.

EXCLUSION CRITERIA

• Patients unable to cooperate.
• Inability to assume a semi-reclining or supine position
• Patients with severe chest wall deformity

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.	1 year

Collaborators and Investigators

• Sponsor: Echosense Ltd.
• Collaborators: Clalit Health Services, Haifa and West Galilee
• Investigators: Study Director: Daniel Weiler, MD, Echosense Ltd.; Principal Investigator: Uzi Milman, MD, Clalit Health Services

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): January 16, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Ultrasound; Asthma; Pulmonary hypertension; Interstitial lung disease; Sarcoidosis; Chronic obstructive lung disease; Doppler; Lung disease diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hypertension; Lung Diseases; Hypertension, Pulmonary; Lung Diseases, Interstitial; Sarcoidosis
• Other Study ID Numbers: DOP09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No