Evaluation of the Surfacer System Approach to Central Venous Access

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Surfacer System Approach to Central Venous Access

Conditions
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Venous Occlusion

Intervention / Treatment
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* Device: Central Venous Access Placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients requiring venous access
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Central Venous Access Placement<br>Central venous access placement | Device: Central Venous Access Placement<br>* Device inserted into the femoral vein to insert a central venous access catheter<br>|

What is the study measuring?
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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 |