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ArterX Safety and Efficacy Study for Cardiac Indications

T

Tenaxis Medical

Status

Completed

Conditions

Vascular Disease

Treatments

Device: ArterX Surgical Sealant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01957904
CLN-015

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

44 participants in 1 patient group

ArterX Surgical Sealant
Other group
Treatment:
Device: ArterX Surgical Sealant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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