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NCT05050799Recruiting

US Post-Market Surveillance Study of the Surfacer System

Merit Medical Systems, Inc.

Start Date

2/8/2022

Completion Date

12/15/2026

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Central Venous Access

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Conditions

Venous Disease

Locations

Pima Heart and Vascular

Tucson, Arizona 85704

United States

Sarasota Memorial Health Care System

Sarasota, Florida 34239

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Ohio State University Hospital

Columbus, Ohio 43210

United States

Baylor Scott & White Heart and Vascular Hospital

Dallas, Texas 75226

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

Flow Vascular Institute

Pasadena, Texas 77504

United States

St. Mark's Hospital

Millcreek, Utah 84124

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States