Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Be male or female, ≥18 years of age at the time of graft placement
- 2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
- 3. Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
- 4. Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study restrictions and return to the site for the required assessments
- 5. Have provided written authorization for use and disclosure of protected health information
- 1. Be participating in a study of another investigational drug or device
- 2. Have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (Lincomycin, Polymyxin B, Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol/glycerin)
- 3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
- 4. Have a history or evidence of severe peripheral vascular disease in the upper extremities
- 5. Have the inability or be unable or unwilling to follow the study visit schedule
- 6. Have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No