Pulmonary EmbolismNCT02652689
Diagnosis of Pulmonary Embolism by Doppler Signals
A study testing Diagnostic ultrasound radiation in people with Pulmonary Embolism, run by Echosense Ltd. at 1 site in Israel.
Trial summary
The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Diagnostic ultrasound radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- Confirmed diagnosis of acute PE on CTA
Who cannot join
- Pregnant women
- Inability to consent
- Patients with severe chest wall deformity
- Previously diagnosed PE
- Pneumonia
- Pulmonary edema
Show all 9Show fewer
- Pneumothorax
- Severe COPD (gold class III, IV)
- Hemodynamically unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transthoracic Parametric Doppler Assessment of Lung Doppler Signals in Acute Pulmonary Embolism
The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were identified. We believe that these newly discovered ultrasound signals might provide a non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.
The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The objective of the study is to evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to determine the potential assessment value of this non-invasive method in this potentially life threatening condition.
- Conditions
- Pulmonary Embolism
- Being tested
- Diagnostic ultrasound radiation
- Keywords
- pulmonary embolism, pulmonary disease, Lung Doppler signals
- Medical subject headings
- Pulmonary Embolism, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ultrasound radiationRadiation
Recording Doppler ultrasound signals from the right chest wall
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic ultrasound | Experimental | Recording Doppler ultrasound signals noninvasively from the right chest wall Receives: Radiation: Diagnostic ultrasound radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT
The obstructed sections will be compared with healthy lung sections
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Gaitini, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652689
- Sponsor's protocol ID
- DOP023
- Status last verified
- Mar 2017
- First submitted
- 5 Jan 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Parametric Doppler Assessment of Lung Doppler Signals in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT02652689
- Acronym / sponsor ID
- DOP023
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, pulmonary disease, Lung Doppler signals
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 12 Jan 2016 (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 LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were identified. We believe that these newly discovered ultrasound signals might provide a non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.
The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The objective of the study is to evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to determine the potential assessment value of this non-invasive method in this potentially life threatening condition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic ultrasound | Experimental | Radiation: Diagnostic ultrasound radiationRecording Doppler ultrasound signals noninvasively from the right chest wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of acute PE on CTA
Key exclusion criteria (9 listed)
- Pregnant women
- Inability to consent
- Patients with severe chest wall deformity
- Previously diagnosed PE
- Pneumonia
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 |
|---|---|---|
| Diagnostic ultrasound radiationRecording Doppler ultrasound signals from the right chest wall | Radiation | Diagnostic ultrasound |
Primary outcome
Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT
Time frame: 30min
The obstructed sections will be compared with healthy lung sections
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Diana Gaitini, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic ultrasound radiation in people with Pulmonary Embolism, 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 1 inclusion and 9 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 8 Feb 2019. 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 was stopped early. 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?
Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT (time frame: 30min). 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 8 Feb 2019.