US Post-Market Surveillance Study of the Surfacer System

Last updated: March 3, 2025
Sponsor: Merit Medical Systems, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Varicose Veins

Cardiovascular Disease

Treatment

Central Venous Access

Clinical Study ID

NCT05050799
CVO-P4-23-01
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Subjects have been referred for placement of central venous access, i.e., placementof catheter, nutritional line, etc.

  2. Subjects with upper body venous occlusions or other conditions that preclude centralvenous access by conventional methods

  3. Subjects are willing and able to give written informed consent

Exclusion

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Central Venous Access
Phase:
Study Start date:
February 08, 2022
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Pima Heart and Vascular

    Tucson, Arizona 85704
    United States

    Completed

  • Sarasota Memorial Health Care System

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Saint Louis University

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Baylor Scott & White Heart and Vascular Hospital

    Dallas, Texas 75226
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Flow Vascular Institute

    Pasadena, Texas 77504
    United States

    Completed

  • St. Mark's Hospital

    Millcreek, Utah 84124
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.