Vascular Disease
Conditions
Keywords
ArterX, surgical sealant
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.
Interventions
DEVICEArterX Surgical Sealant
Sponsors
Tenaxis Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed