Evaluation of the CloSys Closure System as an Adjunct to Standard Compression

Not Applicable

Terminated

• Conditions: Sealing the Arteriotomy
• Interventions: Procedure: Standard compression; Device: CloSys Hemostatic Device (HD)

• Registration Number: NCT00963690
• Lead Sponsor: CloSys Corporation

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the CloSys Hemostatic Device designed to stop bleeding after an interventional procedure.

Detailed Description

To analyze the time to hemostasis (time to stop bleeding), time to ambulation (time to walk) and adverse events.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2013-04-30
• Study Completion: 2013-05-30
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard compression alone	Standard compression	Manual compression arm
CloSys HD with standard compression	CloSys Hemostatic Device (HD)	CloSys Arm
CloSys HD with standard compression	Standard compression	CloSys Arm

Primary Outcome Measures

Name	Time	Method
Time to hemostasis	1 Hour
Time to ambulation	6 Hours

Secondary Outcome Measures

Name	Time	Method
Adverse events	Within 30 days after procedure

Trial Locations

Locations (2)

Cardiovascular Institute of the South; 🇺🇸 Lafayette, Louisiana, United States

Rex Healthcare - Rex Heart and Vascular Research; 🇺🇸 Raleigh, North Carolina, United States