NCT02875899

Surfacer System to Facilitate Access in Venous Occlusions

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

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.

Detailed 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.

Conditions

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

Timeline

• Start date: 2017-02-07
• Primary completion: 2018-09-20
• Completion: 2018-10-04
• First posted: 2016-08-23
• Last updated: 2024-01-26

Locations

4 sites across 3 countries: Austria, Germany, Italy