NCT03234894

Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures

Clinical Study of the WoundCare360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Wound Care 360, Inc. · Industry
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.

Detailed description

The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle. The sample size is 90 patients. The project objective is to demonstrate the safety of the device.

Conditions

• Bleeding

Interventions

Type	Name	Description
DEVICE	SiteSeal Endovascular	to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-09-10
• Completion: 2020-09-01
• First posted: 2017-07-31
• Last updated: 2020-01-30

Regulatory

• FDA-regulated device study