Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

This study is currently recruiting participants.
Verified August 2011 by Echosense Ltd.
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01618721
First received: June 12, 2012
Last updated: August 18, 2013
Last verified: August 2011

June 12, 2012
August 18, 2013
December 2011
June 2014   (final data collection date for primary outcome measure)
Characterization of Lung Doppler signals obtained from different lung diseases. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01618721 on ClinicalTrials.gov Archive Site
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Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)
Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

The study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a Doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. On the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All patients are referred to the outpatient pulmonary clinics or PFT lab for further workup

  • Lung Disease, Chronic Obstructive
  • Lung Disease, Interstitial
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able and willing to provide informed consent
  • Age 18 years or older
  • Clinic and hospital records including additional background medical data such as results of echocardiograms, cardiac catheterization pathology reports etc., available and accessible.
  • Evaluation by a physician who determines that a High Resolution Computed Tomography (HRCT) of the Thorax and pulmonary function tests, including spirometry, lung volumes and diffusion capacity, are indicated as part of the standard clinical care.
  • If full lung function tests are normal imaging with a regular chest x-ray is sufficient.

    • Study Population - subjects will be grouped based on the following criteria after obtaining pulmonary function tests and HRCT of the thorax -

      1. COPD based on clinical assessment and spirometry showing airflow limitation i.e., (FEV1/FVC < 0.70).
      2. Interstitial lung disease (ILD) diagnosed by HRCT.
      3. Control subjects presenting with pulmonary complaints evaluated by full PFTs (spirometry, lung volume and DLCO) and a chest x-ray and/or HRCT , all found to be within normal limits, .

        Exclusion Criteria:

    • Primary or metastatic lung cancer.
    • Acute pneumonia.
    • Concomitant or previous diagnosis of Bronchial Asthma.
    • Patients with severe chest wall deformity
    • Decompensated heart failure or volume overload.
    • Significant right-sided pleural effusion.
Both
18 Years and older
Yes
Contact: Joseph J Chen, M.D. Clin. Assistant Prof. 410-706-0932 jchen1@umm.edu
United States
 
NCT01618721
DOP10
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Echosense Ltd.
Echosense Ltd.
University of Maryland
Not Provided
Echosense Ltd.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP