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

This study has been terminated.
(Low recruiting rate and fulfill requirements)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618721
First Posted: June 13, 2012
Last Update Posted: June 24, 2014
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.
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Echosense Ltd.
  Purpose
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.

Condition
Lung Disease, Chronic Obstructive Lung Disease, Interstitial

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

Resource links provided by NLM:


Further study details as provided by Echosense Ltd.:

Primary Outcome Measures:
  • Characterization of Lung Doppler signals obtained from different lung diseases. [ Time Frame: 1 year ]

Estimated Enrollment: 200
Study Start Date: December 2011
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients are referred to the outpatient pulmonary clinics or PFT lab for further workup
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618721


Locations
United States, Maryland
outpatient pulmonary clinics, University of Maryland Medical school hospital
Baltimore, Maryland, United States
Sponsors and Collaborators
Echosense Ltd.
University of Maryland
  More Information

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01618721     History of Changes
Other Study ID Numbers: DOP10
First Submitted: June 12, 2012
First Posted: June 13, 2012
Last Update Posted: June 24, 2014
Last Verified: August 2011

Keywords provided by Echosense Ltd.:
Chronic obstructive lung disease;
Interstitial lung disease;
Ultrasound Doppler;
Lung disease diagnosis;

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Lung Diseases, Interstitial
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes


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