Surfacer System to Facilitate Access in Venous Occlusions (SAVE)

Merit Medical Systems

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02875899

CP0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)