US Post-Market Surveillance Study of the Surfacer System

NCT05050799 · tracked via the Priya Life Science USA tracker

Sponsor

Merit Medical Systems, Inc

Phase

Observational

Started

2022-02-08

Last updated

2026-11-04

Condition(s) studied

Venous Disease

Investigational drug(s) / intervention(s)

Central Venous Access

Central 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (10)

Facility	City	Region	Status
Pima Heart and Vascular	Tucson	Arizona	Completed
Medstar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
Sarasota Memorial Health Care System	Sarasota	Florida	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
Ohio State University Hospital	Columbus	Ohio	Recruiting
Baylor Scott & White Heart and Vascular Hospital	Dallas	Texas	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	Recruiting
Flow Vascular Institute	Pasadena	Texas	Completed
St. Mark's Hospital	Millcreek	Utah	Recruiting
Sentara Norfolk General Hospital	Norfolk	Virginia	Recruiting

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Other trials for the same condition

The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study Active, not recruiting

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study Active, not recruiting

The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05050799 on ClinicalTrials.gov ↗ ← All trials in the USA