RecruitingNCT05050799

US Post-Market Surveillance Study of the Surfacer System

US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)


Sponsor

Merit Medical Systems, Inc.

Enrollment

30 participants

Start Date

Feb 8, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-market surveillance study follows patients who receive the Surfacer System — a device that creates a new route to insert a central venous catheter (a tube into a large vein) in people whose upper body veins are blocked or unusable. Researchers are tracking how well the device works in real-world clinical settings. You may be eligible if: - You have been referred for placement of a central venous access device (e.g., a nutritional line, medication catheter) - Your upper body veins are blocked or otherwise not accessible using conventional methods - You are willing and able to provide written consent You may NOT be eligible if: - The right femoral vein, right iliac vein, or inferior vena cava (IVC) is blocked - There is an acute blood clot in any vessel the device would need to cross - You have blockages in your arterial (heart-pump-side) blood vessels - You have blockages in the coronary or cerebral blood vessels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(6)

Pima Heart and Vascular

Tucson, Arizona, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Baylor Scott & White Heart and Vascular Hospital

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Flow Vascular Institute

Pasadena, Texas, United States

St. Mark's Hospital

Millcreek, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT05050799


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