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

This study has been completed.
Clalit Health Services, Haifa and West Galilee
Information provided by (Responsible Party):
Echosense Ltd.
ClinicalTrials.gov Identifier:
First received: May 25, 2011
Last updated: January 14, 2015
Last verified: June 2012
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.

Lung Disease, Chronic Obstructive
Lung Disease, Interstitial
Hypertension, Pulmonary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)

Resource links provided by NLM:

Further study details as provided by Echosense Ltd.:

Primary Outcome Measures:
  • Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: August 2011
Study Completion Date: November 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to a large hospital-affiliated community lung clinic.


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.


  • Patients unable to cooperate.
  • Inability to assume a semi-reclining or supine position
  • Patients with severe chest wall deformity
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01361139

Regional Pulmonary Clinic, Clalit Health Services
Haifa, Israel, 3505331
Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services
Haifa, Israel, 35053
Sponsors and Collaborators
Echosense Ltd.
Clalit Health Services, Haifa and West Galilee
Study Director: Daniel Weiler, MD Echosense Ltd.
Principal Investigator: Uzi Milman, MD Clalit Health Services
  More Information

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01361139     History of Changes
Other Study ID Numbers: DOP09 
Study First Received: May 25, 2011
Last Updated: January 14, 2015
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Echosense Ltd.:
Chronic obstructive lung disease
Interstitial lung disease
Pulmonary hypertension
Lung disease diagnosis

Additional relevant MeSH terms:
Chronic Disease
Hypertension, Pulmonary
Lung Diseases
Lung Diseases, Interstitial
Disease Attributes
Lymphatic Diseases
Lymphoproliferative Disorders
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 30, 2016