Surfacer System to Facilitate Access in Venous Occlusions — SAVE  

Chronic Venous Thrombosis Clinical Trial

Official title: Surfacer System to Facilitate Access in Venous Occlusions

Status Completed

Clinical Trial Summary

Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.

Clinical Trial Description

This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated. ;

Related Conditions & MeSH terms

• Chronic Venous Thrombosis
• Thrombosis
• Venous Thrombosis
• Venous Thrombosis Upper Extremity
• Venous Thrombosis Upper Extremity Superficial Veins

• NCT number: NCT02875899
• Study type: Observational [Patient Registry]
• Source: Merit Medical Systems, Inc.
• Status: Completed
• Start date: February 7, 2017
• Completion date: October 4, 2018