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NCT Number: NCT01361139

Diagnosis of Cardio-Pulmonary Pathology Using 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.

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Key information

Conditions

Lung Disease, Chronic Obstructive Asthma Bronchial Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Hypersensitivity, Immediate Hypertension Hypertension, Pulmonary Immune System Diseases Lung Disease, Interstitial Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Lymphatic Diseases Lymphoproliferative Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Sarcoidosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Echosense Ltd.

Industry

Collaborators

  • Clalit Health Services, Haifa and West Galilee

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 26, 2011
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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