ArterX Safety and Efficacy Study for Cardiac Indications

Not Applicable

Completed

• Conditions: Vascular Disease
• Interventions: Device: ArterX Surgical Sealant

• Registration Number: NCT01957904
• Lead Sponsor: Tenaxis Medical, Inc.

Brief Summary

The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-09
• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Completion: 2013-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.

The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.

The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.

The subject is determined by the surgeon to be at risk for poor hemostasis.

Exclusion Criteria

Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.

Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.

Subject is pregnant, may become pregnant or is currently breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ArterX Surgical Sealant	ArterX Surgical Sealant	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with immediate sealing of suture/staple line	during surgery	Immediate sealing of the suture/staple line at point of use upon release of the clamps, as evidenced by an absence of clinically significant bleeding as determined by physician investigator in procedures completed using the ArterX device.

Trial Locations

Locations (1)

Krankenhaus Der Barmherzigen Bruder; 🇩🇪 Trier, Germany