Post-market evaluation of the Surfacer System for central venous access
US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
This study is testing a new device called the Surfacer System to see if it can safely help patients who need central venous access when traditional methods don't work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merit Medical Systems, Inc. Industry-sponsored |
| Locations | 6 sites (Tucson, Arizona and 5 other locations) |
| Trial ID | NCT05050799 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the Surfacer System, a device designed for patients requiring central venous access due to upper body venous occlusions or other complications that prevent conventional access methods. The study will enroll a minimum of 30 patients across up to 12 sites in the United States, with each site limited to 6 subjects. Participants will provide informed consent for the use of their data, and the study will monitor the effectiveness and safety of the device in real-world settings.
Who should consider this trial
Good fit: Ideal candidates include patients referred for central venous access who have upper body venous occlusions or similar conditions.
Not a fit: Patients with occlusions in the right femoral vein, right iliac vein, inferior vena cava, or acute thrombus in vessels to be crossed will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to central venous lines for patients with challenging venous conditions.
How similar studies have performed: While this approach is observational and post-market, similar devices have shown promise in improving central venous access in patients with difficult venous anatomy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tucson, Arizona and 5 other locations
- Pima Heart and Vascular — Tucson, Arizona, United States (Completed)
- Sarasota Memorial Health Care System — Sarasota, Florida, United States (Recruiting)
- Baylor Scott & White Heart and Vascular Hospital — Dallas, Texas, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
- Flow Vascular Institute — Pasadena, Texas, United States (Completed)
- St. Mark's Hospital — Millcreek, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Hannah Susmeyer
- Email: Hannah.Susmeyer@merit.com
- Phone: 978-758-6166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.