NCT03209050

Evaluation of the Surfacer System Approach to Central Venous Access

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Venous Occlusion

Interventions

Type	Name	Description
DEVICE	Central Venous Access Placement	Device inserted into the femoral vein to insert a central venous access catheter

Timeline

• Start date: 2017-12-18
• Primary completion: 2019-05-24
• Completion: 2019-06-01
• First posted: 2017-07-06
• Last updated: 2023-05-30
• Results posted: 2021-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study