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Venous Occlusion

Evaluation of the Surfacer System Approach to Central Venous Access

Sponsored by Merit Medical Systems, Inc.

About this trial

Last updated 2 years ago

Study ID

BVT.Surfacer.17-01

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status