Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635501
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2020-11-13
Brief Title:
AbsorbaSeal ABS 567 Vascular Closure Device Trial
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
Official Title:
Prospective Multicenter Single Arm Pre-CE Marked Study of the AbsorbaSeal ABS 567 Vascular Closure Device
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
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:
None
Brief Summary:
This study investigates the efficacy and safety of the AbsorbaSeal ABS 567 Vascular Closure device VCD for the closure of access site of patients requiring percutaneous diagnostic or interventional procedures An expected total of 50 patients will be enrolled in this study A total of 12 patients 4 patients per site will be treated as roll-in phase prior to enrollment of the first patient The primary objective of this study is to assess the safety and effectiveness of the ABS 567 VCD in sealing the femoral arterial access site following diagnostic or interventional peripheral or coronary procedures Following physician training patients will be enrolled Efficacy and safety analyses will be based on these patients Patients will be followed procedurally to discharge at one month follow-up commitment Secondary objectives are to further characterize adverse events serious and non-serious clinical utility measures and health-related quality of life
Detailed Description:
With the increased number of percutaneous interventions being performed in outpatient settings there is a growing need to obtain safer faster and more secure hemostasis following these procedures Due to its automatic deployment feature and simplicity in operation AbsorbaSeal ABS 567 will lead to more widespread use and improve patient outcomes The active closure system used in the ABS 567 ensures a secure closure The composition of the seal used is completely bio-absorbable and does not require the use of adjunct materials ie collagen sutures staples etc needed in many of the devices currently available
Extensive laboratory testing acute animal labs and deployment in chronic animal studies were performed with ABS 6 After a few device modification to create the improved ABS 567 only minimal confirmatory testing was performed with the current modified ABS 567 The extensive test results on the previous device iterations are used to complete the confirmatory testing of the ABS 567 design
The First in Man FIM trial CP001 supports the initial safety and effectiveness of ABS 567 in humans n20 and was completed prior to application for a pivotal Investigational Device Exemption IDE Study in the United States and a CE Mark Study approval CP004CE in the European Union
The primary objective of this study is to assess the safety and effectiveness of the ABS 567 Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures Patients will be followed procedurally to discharge at one month follow-up commitment Secondary objectives are to further characterize adverse events serious and non-serious clinical utility measures and health-related quality of life
Extensive laboratory testing acute animal labs and deployment in chronic animal studies were performed with ABS 6 After a few device modification to create the improved ABS 567 only minimal confirmatory testing was performed with the current modified ABS 567 The extensive test results on the previous device iterations are used to complete the confirmatory testing of the ABS 567 design
The First in Man FIM trial CP001 supports the initial safety and effectiveness of ABS 567 in humans n20 and was completed prior to application for a pivotal Investigational Device Exemption IDE Study in the United States and a CE Mark Study approval CP004CE in the European Union
The primary objective of this study is to assess the safety and effectiveness of the ABS 567 Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures Patients will be followed procedurally to discharge at one month follow-up commitment Secondary objectives are to further characterize adverse events serious and non-serious clinical utility measures and health-related quality of life
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