US Post-Market Surveillance Study of the Surfacer System

Description

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.

Conditions

Venous Disease

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Study Overview

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Study Details

Study overview

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.

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

US Post-Market Surveillance Study of the Surfacer System

Condition
Venous Disease
Intervention / Treatment

-

Contacts and Locations

Tucson

Pima Heart and Vascular, Tucson, Arizona, United States, 85704

Sarasota

Sarasota Memorial Health Care System, Sarasota, Florida, United States, 34239

Dallas

Baylor Scott & White Heart and Vascular Hospital, Dallas, Texas, United States, 75226

Pasadena

Flow Vascular Institute, Pasadena, Texas, United States, 77504

Millcreek

St. Mark's Hospital, Millcreek, Utah, United States, 84124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merit Medical Systems, Inc.,

Study Record Dates

2025-02-28