Systemic SclerosisNCT02246348
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
A study testing Doppler ultrasound in people with Systemic Sclerosis and Pulmonary Hypertension, run by Echosense Ltd. at 1 site in Israel.
Trial summary
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Pulmonary Hypertension
- What is being tested?
- Doppler ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Dec 2015
- 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
- Able and willing to give signed informed consent prior to enrollment
- Male or female, ≥ 18 years of age
- Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
- Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
- No change in or initiation of PAH specific therapy between the last RHC and TPD
Who cannot join
- People unable or unwilling to give informed consent.
- PCWP or LVEDP > 15 mmHg
- Any PH etiology outside Group 1 (Dana Point, 2008)
- Pregnant women
- Patients having severe chest wall deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension.
The TPD performance in detecting PAH in SSc patients will be assessed in the study.
- Conditions
- Systemic Sclerosis, Pulmonary Hypertension
- Being tested
- Doppler ultrasound
- Keywords
- Systemic Sclerosis, Pulmonary hypertension, Lung Doppler signals
- Medical subject headings
- Scleroderma, Systemic, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundRadiation
Recording Doppler ultrasound noninvasively from the right chest wall
| Study group | Role | What they receive |
|---|---|---|
| Doppler ultrasound | Experimental | Not described Receives: Radiation: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionDec 2015
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexsandra Balbir, Dr, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246348
- Sponsor's protocol ID
- DOP22_2
- Status last verified
- Aug 2014
- First submitted
- 17 Sep 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)
- ClinicalTrials.gov ID
- NCT02246348
- Acronym / sponsor ID
- DOP22_2
- Conditions
- Systemic Sclerosis, Pulmonary Hypertension
- Keywords
- Systemic Sclerosis, Pulmonary hypertension, Lung Doppler signals
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Sep 2014 (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.
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension.
The TPD performance in detecting PAH in SSc patients will be assessed in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doppler ultrasound | Experimental | Radiation: Doppler ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to give signed informed consent prior to enrollment
- Male or female, ≥ 18 years of age
- Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
- Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
- No change in or initiation of PAH specific therapy between the last RHC and TPD
Key exclusion criteria (5 listed)
- People unable or unwilling to give informed consent.
- PCWP or LVEDP > 15 mmHg
- Any PH etiology outside Group 1 (Dana Point, 2008)
- Pregnant women
- Patients having 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 |
|---|---|---|
| Doppler ultrasoundRecording Doppler ultrasound noninvasively from the right chest wall | Radiation | Doppler ultrasound |
Primary outcome
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
Time frame: 12 month
Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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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.
Alexsandra Balbir, Dr 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 Doppler ultrasound in people with Systemic Sclerosis and Pulmonary Hypertension, 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 5 inclusion and 5 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 21 Jan 2016. 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 (reason given: Low recruitment rate). 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?
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC. (time frame: 12 month). 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 21 Jan 2016.