Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03493074
Status:
UNKNOWN
Last Update Posted:
2020-10-09
First Post:
2018-03-20
Brief Title:
Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm VBA
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
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:
VBA
Brief Summary:
This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm AAA and endovascular treatment of AAA EVAR on arterial pulse wave
Detailed Description:
Abdominal aortic aneurysm AAA develops slowly and degeneratively increasing diameter wall tension thinning and decreased wall strength altered compliance which affects the aortic pressure and wave reflection In 50 of cases AAA rupture may lead to death and 50 of the remaining patients referred to hospital die This results in high costs and preventable loss of lives AAA can also be detected by pulse wave PW analysis which could enable development of easy to use affordable and accurate methodology for the detection of AAAs The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities blood-volume related photoplethysmographic PPG PWs and dynamic blood pressure PWs The objective is to study PWs in the detection of AAA and the effects of endovascular repair EVAR and whether adverse effects ie endograft failure can be detected It is hypothesized that AAA and failure of the operation can be detected by PW features especially by printed flexible sensors which will improve the usability patient comfort and safety hygiene The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves at similar accuracy without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings resource reallocation in the healthcare and also improved patient safety and prevention of deaths It could also enable patient-centered comfort follow-up for patients treated by EVAR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None