RECRUITING

US Post-Market Surveillance Study of the Surfacer System

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-02-08
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05050799

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
  2. 2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
  3. 3. Subjects are willing and able to give written informed consent
  1. 1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava
  2. 2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
  3. 3. Occlusion within the arterial system
  4. 4. Occlusion within the coronary or cerebral vasculature

Contacts and Locations

Study Contact

Hannah Susmeyer
CONTACT
978-758-6166
Hannah.Susmeyer@merit.com
Vicky Brunk, RN
CONTACT
717-873-3309
Vicky.Brunk@merit.com

Study Locations (Sites)

Pima Heart and Vascular
Tucson, Arizona, 85704
United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
United States
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, 75226
United States
Flow Vascular Institute
Pasadena, Texas, 77504
United States
St. Mark's Hospital
Millcreek, Utah, 84124
United States

Collaborators and Investigators

Sponsor: Merit Medical Systems, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-08
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2022-02-08
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Venous Disease