Evaluation of the Surfacer System Approach to Central Venous Access (SAVEUS)

Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.

Study Overview

• Status: Completed
• Conditions: Venous Occlusion
• Intervention / Treatment: Device: Central Venous Access Placement

Detailed Description

This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• referred for placement of central venous access catheter
• have limited or diminishing upper body venous access
• have pathology impeding standard access methods
• willing to give written informed consent

Exclusion Criteria:

• occlusion of the right femoral vein
• occlusion of the iliac vein
• occlusion of the inferior vena cava
• contraindicated by physician
• acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous anatomy which precludes a straight line from femoral vein to subclavian
• diagnosed with active pericarditis
• diagnosed with active endocarditis
• suspected pericardial effusion
• known or suspected aneurysm or ectasia of ascending aorta
• innominate artery or subclavian artery
• pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Central Venous Access Placement; Central venous access placement	Device: Central Venous Access Placement; Device inserted into the femoral vein to insert a central venous access catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter	Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted	Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days	7 days

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Collaborators: Meditrial Europe Ltd.
• Investigators: Study Director: Monica Tocchi, MD, Meditrial Europe Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): May 24, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BVT.Surfacer.17-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes