RECRUITING

Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

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Conditions

End-Stage Renal Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,

Official Title

Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study

Quick Facts

Study Start:2023-06-06
Study Completion:2027-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05880537

Participation Criteria

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be male or female, ≥18 years of age at the time of graft placement
  2. 2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
  3. 3. Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
  4. 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. 5. Have provided written authorization for use and disclosure of protected health information
  1. 1. Be participating in a study of another investigational drug or device
  2. 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. 3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
  4. 4. Have a history or evidence of severe peripheral vascular disease in the upper extremities
  5. 5. Have the inability or be unable or unwilling to follow the study visit schedule
  6. 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

Contacts and Locations

Study Contact

Kimberly Dorsch
CONTACT
757-609-4378
kimberly_dorsch@lifenethealth.org
Aaron Bremar
CONTACT
aaron_bremar@lifenethealth.org

Study Locations (Sites)

Infirmary Heath
Mobile, Alabama, 36607
United States
Olive View - UCLA Medical Center
Sylmar, California, 91342
United States
Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: LifeNet Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06
Study Completion Date2027-12-15

Study Record Updates

Study Start Date2023-06-06
Study Completion Date2027-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • End-Stage Renal Disease