Pulmonary PathologiesNCT01225367
The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases
An observational study of Pulmonary Pathologies and Cardio-pulmonary Diseases, run by Echosense Ltd. at 1 site in Israel.
Trial summary
The study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Pathologies, Cardio-pulmonary Diseases
- What is being tested?
- ultrasound doppler monitoring
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Aug 2015
- 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: primary care clinic
Who may be able to join
- Age 18y or older
- patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease
- Patients with CHF
- Patients with pulmonary hypertension
- Patients with COPD
- Patients with Asthma
- Signed informed consent
- Normal subjects
Who cannot join
- Patients with unstable conditions: unstable angina, uncontrolled CHF, etc
- Inability to assume a sitting or supine position
- Patients with severe chest wall deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection and Characterization of Cardio-pulmonary Patho-physiological States and Diseases by Ultrasound Transthoracic Doppler
The study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system.
The system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.
- Conditions
- Pulmonary Pathologies, Cardio-pulmonary Diseases
- Being tested
- ultrasound doppler monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound doppler monitoringDevice
Regular noninvasive chest echo monitoring
| Study group | Role | What they receive |
|---|---|---|
| pulmonary doppler | Not described Receives: Device: ultrasound doppler monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose specific pattern of 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 posted21 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary PathologiesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Person, MD, Principal investigator, Elisha Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225367
- Sponsor's protocol ID
- ES_DOP05
- Status last verified
- May 2011
- First submitted
- 19 Oct 2010
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 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 Ultrasound Transthoracic Doppler
- ClinicalTrials.gov ID
- NCT01225367
- Acronym / sponsor ID
- ES_DOP05
- Conditions
- Pulmonary Pathologies, Cardio-pulmonary Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Oct 2010 (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 is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system.
The system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary doppler | – | Device: ultrasound doppler monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (8 listed)
- Age 18y or older
- patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease
- Patients with CHF
- Patients with pulmonary hypertension
- Patients with COPD
Key exclusion criteria (3 listed)
- Patients with unstable conditions: unstable angina, uncontrolled CHF, etc
- Inability to assume a sitting 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound doppler monitoringRegular noninvasive chest echo monitoring | Device | pulmonary doppler |
Primary outcome
Diagnose specific pattern of 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 13 Aug 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.
Moshe Person, MD principal investigator
Elisha Hospital
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 Pulmonary Pathologies and Cardio-pulmonary Diseases, run by Echosense Ltd. at 1 site 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 8 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 13 Aug 2015. 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 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 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 13 Aug 2015.