Chronic Venous Thrombosis, Venous Thrombosis Upper Extremity, Venous Thrombosis Upper Extremity Superficial Veins
Conditions
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.
Interventions
None listed
Sponsors
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ability to place central venous access catheter using Surfacer system | Procedure | performance evaluated by procedure time measured by time to create access |
| 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 |
| 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 |
Countries
Austria, Germany, Italy
Outcome results
None listed