US Post-Market Surveillance Study of the Surfacer System

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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Disease
• Intervention / Treatment: Device: Central Venous Access

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Casey Holland, MS; Phone Number: 6178420251; Email: casey.holland@merit.com
• Study Contact Backup: Name: Hannah L Bergh, BS; Phone Number: 9787586166; Email: Hannah.bergh@merit.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Completed
      • PIMA Heart and Vascular
  • Florida
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Health Care System
      • Contact: Jason Wagner, MD; Phone Number: 941-917-2225; Email: jwagner@veinsandarteries.com
  • Texas
    • Dallas, Texas, United States, 75226
      • Recruiting
      • Baylor Scott & White Heart and Vascular Hospital
      • Contact: Javier Vasquez, MD; Phone Number: 214-820-1722; Email: Javier.Vasquez@BSWHealth.org
    • Pasadena, Texas, United States, 77504
      • Completed
      • Flow Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 requirements in the labeling of the IFU.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events through 24 hours	no procedural adverse events or peri procedural adverse events	24 hours
Central Venous Access operational	safe insertion of the device to facilitate central venous access	24 hours

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Investigators: Study Director: Laura Minarsch, BS, Clinical Affairs Director

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): August 10, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CVO-P4-23-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No