ArterX Safety and Efficacy Study for Cardiac Indications

NCT01957904 | Completed

• 1 other identifier: CLN-015
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Disease

Keywords

ArterX, surgical sealant

Outcome Measures

Primary Outcomes (1)

• Number of subjects with immediate sealing of suture/staple line

  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.

  during surgery

Study Arms (1)

ArterX Surgical Sealant

OTHER

Device: ArterX Surgical Sealant

Interventions

ArterX Surgical Sealant DEVICE

ArterX Surgical Sealant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tenaxis Medical, Inc.: lead

Study Sites (1)

Krankenhaus Der Barmherzigen Bruder

Trier, Germany

Location

Related Publications (1)

• Skorpil J, Paraforos A, Mandak J, Cohn WE, Hajek T, Friedrich I. Effective and rapid sealing of coronary, aortic and atrial suture lines dagger. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):720-4; discussion 724. doi: 10.1093/icvts/ivv061. Epub 2015 Mar 24.

  PMID: 25810290 RESULT

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

DE (1)