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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01361139
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Clalit Health Services, Haifa and West Galilee
Information provided by (Responsible Party):
Echosense Ltd.

Tracking Information
First Submitted Date May 25, 2011
First Posted Date May 26, 2011
Last Update Posted Date January 16, 2015
Study Start Date August 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 18, 2013)
Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. [ Time Frame: 1 year ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis of Cardio-Pulmonary Pathology Using Transthoracic Parametric Doppler (TPD)
Official Title Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients referred to a large hospital-affiliated community lung clinic.
Condition
  • Lung Disease, Chronic Obstructive
  • Lung Disease, Interstitial
  • Asthma
  • Sarcoidosis
  • Hypertension, Pulmonary
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 14, 2015)
500
Original Estimated Enrollment
 (submitted: May 25, 2011)
80
Actual Study Completion Date November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01361139
Other Study ID Numbers DOP09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Echosense Ltd.
Study Sponsor Echosense Ltd.
Collaborators Clalit Health Services, Haifa and West Galilee
Investigators
Study Director: Daniel Weiler, MD Echosense Ltd.
Principal Investigator: Uzi Milman, MD Clalit Health Services
PRS Account Echosense Ltd.
Verification Date June 2012