Evaluation of the Surfacer System Approach to Central Venous Access

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2019-06-01

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.

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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.

Conditions

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Venous Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients requiring venous access

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Central Venous Access Placement

Central venous access placement

Group Type OTHER

Central Venous Access Placement

Intervention Type DEVICE

Device inserted into the femoral vein to insert a central venous access catheter

Interventions

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Central Venous Access Placement

Device inserted into the femoral vein to insert a central venous access catheter

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No