Lung Disease, Chronic ObstructiveNCT01618721
Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)
An observational study of Lung Disease, Chronic Obstructive and Lung Disease, Interstitial, run by Echosense Ltd. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Disease, Chronic Obstructive, Lung Disease, Interstitial
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients are referred to the outpatient pulmonary clinics or PFT lab for further workup
Who may be able to join
- 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 -
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- COPD based on clinical assessment and spirometry showing airflow limitation i.e., (FEV1/FVC < 0.70).
- Interstitial lung disease (ILD) diagnosed by HRCT.
- 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, .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
outpatient pulmonary clinics, University of Maryland Medical school hospital
Baltimore, Maryland
About this study
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.
- Keywords
- Chronic obstructive lung disease;, Interstitial lung disease;, Ultrasound Doppler;, Lung disease diagnosis;
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Lung Doppler signals obtained from different lung diseases.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2013
Why it stopped: Low recruiting rate and fulfill requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618721
- Sponsor's protocol ID
- DOP10
- Status last verified
- Aug 2011
- First submitted
- 12 Jun 2012
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)
- ClinicalTrials.gov ID
- NCT01618721
- Acronym / sponsor ID
- DOP10
- Keywords
- Chronic obstructive lung disease;, Interstitial lung disease;, Ultrasound Doppler;, Lung disease diagnosis;
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruiting rate and fulfill requirements
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are referred to the outpatient pulmonary clinics or PFT lab for further workup
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of Lung Doppler signals obtained from different lung diseases.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Low recruiting rate and fulfill requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Disease, Chronic Obstructive and Lung Disease, Interstitial, run by Echosense Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruiting rate and fulfill requirements). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Lung Doppler signals obtained from different lung diseases. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.