Evaluation of the Surfacer System Approach to Central Venous Access

Not Applicable

Completed

• Conditions: Venous Occlusion
• Interventions: Device: Central Venous Access Placement

• Registration Number: NCT03209050
• Lead Sponsor: Merit Medical Systems, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2017-12-18
• Primary Completion: 2019-05-24
• Study Completion: 2019-06-01
• Results First Submitted: 2020-07-30
• Results First Submitted QC: 2021-07-21
• Results First Posted: 2021-08-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Central Venous Access Placement	Central Venous Access Placement	Central venous access placement

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	7 days	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

Trial Locations

Locations (1)

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States