Venous Disease
Conditions
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.
Interventions
DEVICECentral Venous Access
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.
Sponsors
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc. 2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods 3. Subjects are willing and able to give written informed consent
Exclusion criteria
1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava 2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian) 3. Occlusion within the arterial system 4. Occlusion within the coronary or cerebral vasculature
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Venous Access operational | 24 hours | safe insertion of the device to facilitate central venous access |
| Incidence of adverse events through 24 hours | 24 hours | no procedural adverse events or peri procedural adverse events |
Countries
United States
Contacts
Primary ContactHannah Susmeyer
Backup ContactVicky Brunk, RN
Outcome results
None listed