US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Merit Medical Systems, Inc.
- Enrollment
- 30
- Locations
- 15
- Primary Endpoint
- Incidence of adverse events through 24 hours
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence of adverse events through 24 hours
Time Frame: 24 hours
no procedural adverse events or peri procedural adverse events
Central Venous Access operational
Time Frame: 24 hours
safe insertion of the device to facilitate central venous access
Secondary Outcomes
No secondary outcomes reported