NCT03730571

The AbsorbaSeal Vascular Closure Device Trial

Prospective, Multi-center, Non-Randomized Controlled Trial of Vascular Closure Using the AbsorbaSeal 6 French Vascular Closure Device

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: ID3 Medical · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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 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 (i.e. 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 (N=20). 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	AbsorbaSeal 6Fr Vascular Closure Device	Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device

Timeline

• Start date: 2017-08-16
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2018-11-05
• Last updated: 2021-09-08

Locations

3 sites across 1 country: Belgium