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

Merit Medical Systems

Status: Completed

Conditions: Venous Occlusion

Treatments: Device: Central Venous Access Placement

Study type: Interventional

Funder types: Industry

Identifiers

NCT03209050

BVT.Surfacer.17-01

Details and patient eligibility

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Central Venous Access Placement

Other group

Description:

Central venous access placement

Treatment:

Device: Central Venous Access Placement