US Post-Market Surveillance Study of the Surfacer System
ConditionVenous Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerit Medical Systems, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
Subjects are willing and able to give written informed consent
Disqualifiers
Occlusion of the right femoral vein, right iliac vein or inferior vena cava
Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
Occlusion within the arterial system
Occlusion within the coronary or cerebral vasculature
Trial design
Treatments tested in this trial
- Central Venous Access
Treatment groups
No treatment groups listed
Locations
9Arizona
Pima Heart and Vascular85704, Tucson United States
Florida
Sarasota Memorial Health Care System34239, Sarasota United States
Georgia
Emory University Hospital30322, Atlanta United States
Ohio
Ohio State University Hospital43210, Columbus United States
Sponsors and collaborators
Merit Medical Systems, Inc.
Lead sponsor
Source ClinicalTrials.gov