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

Sponsor

Echosense Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01361139

Collaborator

Clalit Health Services, Haifa and West Galilee (Other)

500

Enrollment

Locations

Duration (Months)

250

Patients Per Site

6.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Lung Disease, Chronic Obstructive Lung Disease, Interstitial Asthma Sarcoidosis Hypertension, Pulmonary

Study Design

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 :

Aug 1, 2011

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Pulmonary Clinic, Clalit Health Services	Haifa		Israel	3505331
2	Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services	Haifa		Israel	35053