US Post-Market Surveillance Study of the Surfacer System
- Conditions
- Venous Disease
- Registration Number
- NCT05050799
- Lead Sponsor
- Merit Medical Systems, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events through 24 hours 24 hours no procedural adverse events or peri procedural adverse events
Central Venous Access operational 24 hours safe insertion of the device to facilitate central venous access
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Pima Heart and Vascular
🇺🇸Tucson, Arizona, United States
Sarasota Memorial Health Care System
🇺🇸Sarasota, Florida, United States
Baylor Scott & White Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Flow Vascular Institute
🇺🇸Pasadena, Texas, United States
St. Mark's Hospital
🇺🇸Millcreek, Utah, United States