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

Lung Disease, Interstitial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01618721
• Other study ID #: DOP10
• Status: Terminated
• Phase: N/A
• First received: June 12, 2012
• Last updated: June 23, 2014
• Start date: December 2011

Study information

• Verified date: August 2011
• Source: Echosense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Disease, Chronic Obstructive
• Lung Disease, Interstitial
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
United States	outpatient pulmonary clinics, University of Maryland Medical school hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Echosense Ltd.	University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of Lung Doppler signals obtained from different lung diseases.		1 year	No