Evaluation of the Surfacer System Approach to Central Venous Access

Venous Occlusion Clinical Trial

— SAVEUS  

Official title:

Evaluation of the Surfacer System Approach to Central Venous Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209050
• Other study ID #: BVT.Surfacer.17-01
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2023
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Venous Occlusion

Intervention

Device:
• Central Venous Access Placement
Device inserted into the femoral vein to insert a central venous access catheter

Locations

Country	Name	City	State
United States	Houston Methodist Research Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.	Meditrial Europe Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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