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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Central Venous Access | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Central Venous Access operational | safe insertion of the device to facilitate central venous access | 24 hours |
| Incidence of adverse events through 24 hours | no procedural adverse events or peri procedural adverse events | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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 requirements in the labeling of the IFU.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Susmeyer | Contact | 978-758-6166 | Hannah.Susmeyer@merit.com | |
| Vicky Brunk, RN | Contact | 717-873-3309 | Vicky.Brunk@merit.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pima Heart and Vascular | Completed | Tucson | Arizona | 85704 | United States | |
| Sarasota Memorial Health Care System |
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| Recruiting |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| Ohio State University Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
| Baylor Scott & White Heart and Vascular Hospital | Recruiting | Dallas | Texas | 75226 | United States |
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
| Flow Vascular Institute | Completed | Pasadena | Texas | 77504 | United States |
| St. Mark's Hospital | Recruiting | Millcreek | Utah | 84124 | United States |
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |