Surfacer System to Facilitate Access in Venous Occlusions

Completed

• Conditions: Chronic Venous Thrombosis; Venous Thrombosis Upper Extremity; Venous Thrombosis Upper Extremity Superficial Veins

• Registration Number: NCT02875899
• Lead Sponsor: Merit Medical Systems, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Study Start: 2017-02-07
• Primary Completion: 2018-09-20
• Study Completion: 2018-10-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients referred for placement of a central venous catheter

• patients with limited or diminishing upper body venous access
• pathology impeding standard access methods
• signed informed consent

Exclusion Criteria

• vulnerable subjects or incapable of giving consent
• contraindications to central venous access based on treating physicians opinion or standard of care
• occlusion of the right femoral vein
• occlusion of the iliac vein
• occlusion of the inferior vena
• acute thrombosis within a vessel (IVC, brachiocephalic and subclavian)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of all acute safety and device related serious adverse event recorded on case report forms	Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.	overall complication rate compared to safety data

Secondary Outcome Measures

Name	Time	Method
Surfacer system advancement of the exit wire outside the vein	procedure	Ability to advance system from femoral vein to supraclavicular exit as measured by time
Ability to place central venous access catheter using Surfacer system	Procedure	performance evaluated by procedure time measured by time to create access
Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents	procedure	introducing a standard central venous access catheter over the needle wire

Trial Locations

Locations (4)

Azienda Ospedaliera San Carlo Borromeo; 🇮🇹 Milan, Italy

Schon Klinik; 🇩🇪 Dusseldorf, Germany

University Hospital of Cologne; 🇩🇪 Cologne, Germany

University of Vienna; 🇦🇹 Vienna, Waehringer Guertel 18-20, Austria