Lung Disease, Chronic ObstructiveNCT01361139
Diagnosis of Cardio-Pulmonary Pathology Using Transthoracic Parametric Doppler (TPD)
An observational study of Lung Disease, Chronic Obstructive and Lung Disease, Interstitial, run by Echosense Ltd. at 2 sites in Israel.
Trial summary
This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease, Chronic Obstructive, Lung Disease, Interstitial, Asthma
- How many people
- 500 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2011to Nov 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to a large hospital-affiliated community lung clinic.
Who may be able to join
- Age 18 years or older Patients who are clinically suspected of having pulmonary, cardiac or Cardio-pulmonary disease preferably any one or more of the conditions listed below:
- Patients with CHF
- Patients with pulmonary hypertension with documented right heart catheterization data
- Patients with COPD in two subgroups:
- Emphysema, (evidence of emphysema on High Resolution Computed Tomography, (HRCT) and airflow limitation of GOLD II severity who have had Carbon Monoxide Diffusing capacity, (DLCO) and Residual Volume(RV) measured, or patients without HRCT with measurements of lung volumes and diffusing capacity with Total Lung Capacity (TLC) ≥1.0 predicted, RV/TLC ≥0.4, DLCO ≤ 0.7 predicted.
- Chronic Bronchitis (No evidence of Emphysema on HRCT and/or no evidence of air-trapping or reduced DLCO.)
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- Patients with asthma according to ATS/ERS definition,
- Patients with interstitial lung disease (ILD) of any etiology including sarcoidosis diagnosed by HRCT in sub groups as follows:
- Mild ILD (TLC 0.71-0.79 predicted, DLCO ≥ 0.71 predicted)
- Moderate and severe ILD (TLC ≤ 0.7 predicted, DLCO ≤ 0.7 predicted)
- Signed informed consent.
- Patients with sarcoidosis without evidence of parenchymal lung disease defined as normal DLCO and/or HRCT.
Who cannot join
- Patients unable to cooperate.
- Inability to assume a semi-reclining or supine position
- Patients with severe chest wall deformity
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Regional Pulmonary Clinic, Clalit Health Services
Haifa, 3505331
Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services
Haifa, 35053
About this study
Official title: Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)
This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and the unique software the investigators have developed analyzes the signal reflected back from within the lung. On the basis of pilot studies performed previously the investigators expect to receive different signals from different diseases. The investigators seek to further characterize these signals to enable accurate diagnosis of different lung diseases using our technology.
- Conditions
- Lung Disease, Chronic Obstructive, Lung Disease, Interstitial, Asthma, Sarcoidosis, Hypertension, Pulmonary
- Keywords
- Chronic obstructive lung disease, Interstitial lung disease, Asthma, Sarcoidosis, Pulmonary hypertension, Ultrasound, Doppler, Lung disease diagnosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma, Sarcoidosis, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.
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 posted26 May 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionNov 2014
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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services, Haifa and West Galilee
- Responsible party
- Sponsor
- Investigators
- Daniel Weiler, MD, Study director, Echosense Ltd.Uzi Milman, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361139
- Sponsor's protocol ID
- DOP09
- Status last verified
- Jun 2012
- First submitted
- 25 May 2011
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)
- ClinicalTrials.gov ID
- NCT01361139
- Acronym / sponsor ID
- DOP09
- Conditions
- Lung Disease, Chronic Obstructive, Lung Disease, Interstitial, Asthma, Sarcoidosis, Hypertension, Pulmonary
- Keywords
- Chronic obstructive lung disease, Interstitial lung disease, Asthma, Sarcoidosis, Pulmonary hypertension, Ultrasound, Doppler, Lung disease diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services, Haifa and West Galilee
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 May 2011 (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.
This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and the unique software the investigators have developed analyzes the signal reflected back from within the lung. On the basis of pilot studies performed previously the investigators expect to receive different signals from different diseases. The investigators seek to further characterize these signals to enable accurate diagnosis of different lung diseases using our technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to a large hospital-affiliated community lung clinic.
Key inclusion criteria (12 listed)
- Age 18 years or older Patients who are clinically suspected of having pulmonary, cardiac or Cardio-pulmonary disease preferably any one or more of the conditions listed below:
- Patients with CHF
- Patients with pulmonary hypertension with documented right heart catheterization data
- Patients with COPD in two subgroups:
- Patients with asthma according to ATS/ERS definition,
Key exclusion criteria (3 listed)
- Patients unable to cooperate.
- Inability to assume a semi-reclining or supine position
- Patients with severe chest wall deformity
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
Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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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.
Daniel Weiler, MD study director
Echosense Ltd.
Uzi Milman, MD principal investigator
Clalit Health Services
2 sites 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 2 sites in Israel.
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 12 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. (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 16 Jan 2015.