Surfacer System to Facilitate Access in Venous Occlusions (SAVE)
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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.
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.
Absence of all acute safety and device related serious adverse event recorded on case report forms [ Time Frame: 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 :
Ability to place central venous access catheter using Surfacer system [ Time Frame: Procedure ]
performance evaluated by procedure time measured by time to create access
Surfacer system advancement of the exit wire outside the vein [ Time Frame: procedure ]
Ability to advance system from femoral vein to supraclavicular exit as measured by time
Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents [ Time Frame: procedure ]
introducing a standard central venous access catheter over the needle wire
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients requiring central venous access for:
delivery of any pharmacological therapy
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
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)