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.
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.
Study Type
OBSERVATIONAL
Enrollment
30
The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
Pima Heart and Vascular
Tucson, Arizona, United States
COMPLETEDSarasota Memorial Health Care System
Sarasota, Florida, United States
RECRUITINGEmory University Hospital
Central Venous Access operational
safe insertion of the device to facilitate central venous access
Time frame: 24 hours
Incidence of adverse events through 24 hours
no procedural adverse events or peri procedural adverse events
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atlanta, Georgia, United States
Ohio State University Hospital
Columbus, Ohio, United States
RECRUITINGBaylor Scott & White Heart and Vascular Hospital
Dallas, Texas, United States
RECRUITINGThe University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGFlow Vascular Institute
Pasadena, Texas, United States
COMPLETEDSt. Mark's Hospital
Millcreek, Utah, United States
RECRUITINGSentara Norfolk General Hospital
Norfolk, Virginia, United States
RECRUITING