US Post-Market Surveillance Study of the Surfacer System
Start Date
2/8/2022
Completion Date
12/15/2026
Summary
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.
Detailed Description
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Central Venous Access
Conditions
Locations
Pima Heart and Vascular
Tucson, Arizona 85704
United States
Sarasota Memorial Health Care System
Sarasota, Florida 34239
United States
Emory University Hospital
Atlanta, Georgia 30322
United States
Ohio State University Hospital
Columbus, Ohio 43210
United States
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas 75226
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
Flow Vascular Institute
Pasadena, Texas 77504
United States
St. Mark's Hospital
Millcreek, Utah 84124
United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States