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

This study is currently recruiting participants.
Verified June 2012 by Echosense Ltd.
Sponsor:
Collaborator:
Clalit Health Services, Haifa and West Galilee
Information provided by (Responsible Party):
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01361139
First received: May 25, 2011
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Echosense Ltd.:

Estimated Enrollment: 450
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361139

Contacts
Contact: Daniel Weiler, MD +972-54-5322422 weiler@echosense.co.ilUz
Contact: Uzi Milmann, MD +972-50-6261360 uzimi@clalit.org.il

Locations
Israel
Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services Not yet recruiting
Haifa, Israel, 35053
Principal Investigator: Uzi Milman, MD            
Sub-Investigator: Arie Brik            
Sub-Investigator: Assaf Jacobi, MD            
Sub-Investigator: Svetlana Pojurovsky, MD            
Sub-Investigator: Michal Shteinberg, MD            
Sub-Investigator: DANIEL WEILER, MD            
Regional Pulmonary Clinic, Clalit Health Services Recruiting
Haifa, Israel, 3505331
Contact: DANIEL WEILER, MD     +972545322422     dani@echosense.co.il    
Contact: RAMI UNTERMAN, ISRAEL     +972527077224     rami@echosense.co.il    
Sub-Investigator: DANIEL WEILER, MD            
Principal Investigator: UZI MILMAN, MD            
Sponsors and Collaborators
Echosense Ltd.
Clalit Health Services, Haifa and West Galilee
Investigators
Study Director: Daniel Weiler, MD Echosense Ltd.
Principal Investigator: Uzi Milman, MD Clalit Health Services
  More Information

No publications provided

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01361139     History of Changes
Other Study ID Numbers: DOP09
Study First Received: May 25, 2011
Last Updated: June 5, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Echosense Ltd.:
Chronic obstructive lung disease
Interstitial lung disease
Asthma
Sarcoidosis
 Pulmonary hypertension
Ultrasound
Doppler
Lung disease diagnosis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Lung Diseases, Obstructive
Asthma
Chronic Disease
Hypertension
Hypertension, Pulmonary
Sarcoidosis
Bronchial Diseases
Respiratory Tract Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013