Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02392260
Status:
UNKNOWN
Last Update Posted:
2015-03-18
First Post:
2015-03-12
Brief Title:
Non-invasive Screening of the Status of the Vascular System Feasibility Test
Sponsor:
University of Pavia
Organization:
University of Pavia
Study Overview
Official Title:
Non-invasive Screening of the Status of the Vascular System Feasibility Test
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NISTAS1
Brief 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 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 andor 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 distancedisplacementvibration 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 25 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 v10 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
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 distancedisplacementvibration 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 25 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 v10 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None