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

NCT01361139 | Completed

• 1 other identifier: DOP09
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Disease, Chronic Obstructive; Lung Disease, Interstitial; Asthma; Sarcoidosis; Hypertension, Pulmonary

Keywords

Chronic obstructive lung disease; Interstitial lung disease; Asthma; Sarcoidosis; Pulmonary hypertension; Ultrasound; Doppler; Lung disease diagnosis

Outcome Measures

Primary Outcomes (1)

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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to a large hospital-affiliated community lung clinic.

You may qualify if:

• 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.

You may not qualify if:

• Patients unable to cooperate.
• Inability to assume a semi-reclining or supine position
• Patients with severe chest wall deformity

Sponsors & Collaborators

• Echosense Ltd.: lead
• Clalit Health Services, Haifa and West Galilee: collaborator

Study Sites (2)

Regional Pulmonary Clinic, Clalit Health Services

Haifa, 3505331, Israel

Location

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

Haifa, 35053, Israel

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Weiler, MD

  Echosense Ltd.

  STUDY DIRECTOR

• Uzi Milman, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 26, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 16, 2015

Record last verified: 2012-06

Locations

IL (2)