Post-market evaluation of the Surfacer System for central venous access

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medstar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Sarasota Memorial Health Care System
  Sarasota, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Ohio State University Hospital
  Columbus, Ohio, 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

Study contacts

• Study coordinator: Hannah Susmeyer
• Email: Hannah.Susmeyer@merit.com
• Phone: 978-758-6166

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.