Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730571
Status:
TERMINATED
Last Update Posted:
2021-09-08
First Post:
2018-09-28
Brief Title:
The AbsorbaSeal Vascular Closure Device Trial
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
Official Title:
Prospective Multi-center Non-Randomized Controlled Trial of Vascular Closure Using the AbsorbaSeal 6 French Vascular Closure Device
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient closure
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 6Fr 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 AbsorbaSeal 6Fr VCD Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures Following physician training patients will be enrolled Efficacy and safety analyses will be based on these patientsPatients 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 faster safer and more secure hemostasis following these outpatient procedures CyndRx believes an improved VCD will lead to more widespread use and ultimately improve patient outcomes The AbsorbaSeal Vascular Closure Device ABS-6 has been developed to meet this need The ease of use and automatic deployment of the device will eliminate the learning curve associated with the use of VCDs The active closure system used in the ABS-6 ensures a secure closure with every deployment 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
The First In Man FIM trial demonstrated the safety and efficacy of the ABS-6 system in humans N20 To further evaluate the safety and efficacy up to 50 patients will be enrolled in the CP002CE-study
The primary objective of this study is to assess the safety and effectiveness of the AbsorbaSeal 6Fr VCD 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
The First In Man FIM trial demonstrated the safety and efficacy of the ABS-6 system in humans N20 To further evaluate the safety and efficacy up to 50 patients will be enrolled in the CP002CE-study
The primary objective of this study is to assess the safety and effectiveness of the AbsorbaSeal 6Fr VCD 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