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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361139
• Other study ID #: DOP09
• Status: Completed
• Phase: N/A
• First received: May 25, 2011
• Last updated: January 14, 2015
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: June 2012
• Source: Echosense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Hypertension, Pulmonary
• Lung Disease, Chronic Obstructive
• Lung Disease, Interstitial
• Lung Diseases
• Lung Diseases, Interstitial
• Sarcoidosis

Locations

Country	Name	City	State
Israel	Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services	Haifa
Israel	Regional Pulmonary Clinic, Clalit Health Services	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Echosense Ltd.	Clalit Health Services, Haifa and West Galilee

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.		1 year	No