Text Size

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: NA
Last verified: August 2011
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 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:   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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618721

Contacts
Contact: Joseph J Chen, M.D. Clin. Assistant Prof. 410-706-0932 jchen1@umm.edu

Locations
United States, Maryland
outpatient pulmonary clinics, University of Maryland Medical school hospital Recruiting
Baltimore, Maryland, United States
Contact: Joseph J Chen, Dr     410-706-0932     jchen1@umm.edu    
Principal Investigator: Joseph J Chen, M.D.            
Sponsors and Collaborators
Echosense Ltd.
University of Maryland
  More Information

No publications provided

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01618721     History of Changes
Other Study ID Numbers: DOP10
Study First Received: June 12, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013