To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method).NISTAS1NCT02392260
Non-invasive Screening of the Status of the Vascular System: Feasibility Test
A study testing Vasculight in people with To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method)., run by University of Pavia.
Trial summary
This project is part of the EU funded project NISTAS. NISTAS aims at the development of a new medical device for non-contact, non-invasive screening of the health status of the vascular system of adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method).
- What is being tested?
- Vasculight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
Who cannot join
- Systolic BP >160 mmHg or diastolic BP >100 mmHg
- Treated hypertension
- Diagnosis of type 1 or type 2 diabetes mellitus
- Treated hypercholesterolaemia
- Past or current, symptomatic or proven, coronary artery disease
- Clinical cerebrovascular disease
Show all 15Show fewer
- Carotid arterial stenosis
- Severe peripheral vascular disease
- Hypertrophic or dilated cardiomyopathy
- Congestive heart failure
- Heart valve disease
- Previous cardiac surgery
- Congenital heart disease
- Other systemic diseases such as cancers, endocrine diseases and autoimmune diseases
- Any regular drug treatment
Trial locations and contacts
No sites are listed yet.
About this study
This project is part of the EU funded project NISTAS. NISTAS aims at the development of a new medical device for non-contact, non-invasive screening of the health status of the vascular system of adult subjects. The instrument, called VascuLight, is intended to be deployed at out-patient points-of-care and hospitals, and it provides output parameters related to the PWV as measured at local and/or at regional level.
NISTAS brings together four European SMEs in four different, but complementary, technology areas (JULIGHT, ECLEXYS, EPI-LIGHT, OIP) and links them with five RTD Performers (UNIPV, OSM, CORK UNIVERSITY, Saphyrion, Eudax srl ) to develop new knowledge and a new medical device which will have significant commercial benefits for all of the SME partners.
Read more
VascuLight responds to an unmet need in the medical diagnosis practice: the request for a fast and sustainable method for the screening of the health of the vascular system in large series, capable of providing a reliable indicator of the cardiovascular risk of the screened subjects.
The VascuLight idea is founded on a paradigm shift: bringing and adapting to the biomedical field measurement techniques that are to date confined to the industrial environment. NISTAS will develop new non-contact distance/displacement/vibration sensors based on a variant of the well-known and reliable laser triangulation technique.
JUL and UNIPV have carried out proof-of-concept, in-vivo tests of the VascuLight approach to demonstrate that the concept is realistic and attainable. Results have been obtained using Laser Doppler Vibrometry (LDV), a displacement-measuring technique based on the principle of light interference, and an area where both JUL and UNIPV have made important contributions. In the tests it was possible to use TWO small LDV optical heads to simultaneously measure the pulse wave in two points on the carotid spaced by 2.5 cm, allowing for the calculation of the time-delay between the pulse waves, and thus providing a direct local measurement of the PWV.
The aim of the study is to test the implemented contactless optical technique for the measurement of the PWV and the arterial stiffness at the carotid artery level.
To evaluate the validity of the measure method, the investigators will compare Vasculight v1.0 PWV measures with those obtained from e-tracking (echocardiographic method) . The main idea is to compare the distribution of measures (comparable mean and standard deviation) in the same mixed adult population, using the two different methods.
- Being tested
- Vasculight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasculightDevice
Comparative measre of Pulse Wave velocity with both Vasculight prototype and Echocardiographic machine.
| Study group | Role | What they receive |
|---|---|---|
| Vasculight prototype zero level | Experimental | Not described Receives: Device: Vasculight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave velocity
Bland Altmann test and ROC analysis will be used to compare the 2 methods
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method).Studies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Favalli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392260
- Sponsor's protocol ID
- 20140008054
- Acronym
- NISTAS1
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Screening of the Status of the Vascular System: Feasibility Test
- ClinicalTrials.gov ID
- NCT02392260
- Acronym / sponsor ID
- NISTAS1 / 20140008054
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 18 Mar 2015 (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 project is part of the EU funded project NISTAS. NISTAS aims at the development of a new medical device for non-contact, non-invasive screening of the health status of the vascular system of adult subjects. The instrument, called VascuLight, is intended to be deployed at out-patient points-of-care and hospitals, and it provides output parameters related to the PWV as measured at local and/or at regional level.
NISTAS brings together four European SMEs in four different, but complementary, technology areas (JULIGHT, ECLEXYS, EPI-LIGHT, OIP) and links them with five RTD Performers (UNIPV, OSM, CORK UNIVERSITY, Saphyrion, Eudax srl ) to develop new knowledge and a new medical device which will have significant commercial benefits for all of the SME partners.
VascuLight responds to an unmet need in the medical diagnosis practice: the request for a fast and sustainable method for the screening of the health of the vascular system in large series, capable of providing a reliable indicator of the cardiovascular risk of the screened subjects.
The VascuLight idea is founded on a paradigm shift: bringing and adapting to the biomedical field measurement techniques that are to date confined to the industrial environment. NISTAS will develop new non-contact distance/displacement/vibration sensors based on a variant of the well-known and reliable laser triangulation technique.
JUL and UNIPV have carried out proof-of-concept, in-vivo tests of the VascuLight approach to demonstrate that the concept is realistic and attainable. Results have been obtained using Laser Doppler Vibrometry (LDV), a displacement-measuring technique based on the principle of light interference, and an area where both JUL and UNIPV have made important contributions. In the tests it was possible to use TWO small LDV optical heads to simultaneously measure the pulse wave in two points on the carotid spaced by 2.5 cm, allowing for the calculation of the time-delay between the pulse waves, and thus providing a direct local measurement of the PWV.
The aim of the study is to test the implemented contactless optical technique for the measurement of the PWV and the arterial stiffness at the carotid artery level.
To evaluate the validity of the measure method, the investigators will compare Vasculight v1.0 PWV measures with those obtained from e-tracking (echocardiographic method) . The main idea is to compare the distribution of measures (comparable mean and standard deviation) in the same mixed adult population, using the two different methods.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vasculight prototype zero level | Experimental | Device: Vasculight |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65
Key exclusion criteria (15 listed)
- Systolic BP >160 mmHg or diastolic BP >100 mmHg
- Treated hypertension
- Diagnosis of type 1 or type 2 diabetes mellitus
- Treated hypercholesterolaemia
- Past or current, symptomatic or proven, coronary artery disease
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 |
|---|---|---|
| VasculightComparative measre of Pulse Wave velocity with both Vasculight prototype and Echocardiographic machine. | Device | Vasculight prototype zero level |
Primary outcome
Pulse Wave velocity
Time frame: 1 month
Bland Altmann test and ROC analysis will be used to compare the 2 methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Vasculight in people with To Evaluate the Validity of the Measure Method, we Will Compare Vasculight v1.0 PWV Measures With Those Obtained From E-tracking (Echocardiographic Method)., run by University of Pavia.
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 15 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Favalli, BME (0039 0382 501487, v.favalli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave velocity (time frame: 1 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 18 Mar 2015.