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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01361139
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : January 16, 2015
Clalit Health Services, Haifa and West Galilee
Information provided by (Responsible Party):
Echosense Ltd.

Brief Summary:
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.

Condition or disease
Lung Disease, Chronic Obstructive Lung Disease, Interstitial Asthma Sarcoidosis Hypertension, Pulmonary

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)
Study Start Date : August 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Primary Outcome Measures :
  1. Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01361139

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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
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Study Director: Daniel Weiler, MD Echosense Ltd.
Principal Investigator: Uzi Milman, MD Clalit Health Services
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Responsible Party: Echosense Ltd. Identifier: NCT01361139    
Other Study ID Numbers: DOP09
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: June 2012
Keywords provided by Echosense Ltd.:
Chronic obstructive lung disease
Interstitial lung disease
Pulmonary hypertension
Lung disease diagnosis
Additional relevant MeSH terms:
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Lung Diseases
Hypertension, Pulmonary
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases