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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Absence of all acute safety and device related serious adverse event recorded on case report forms | overall complication rate compared to safety data | Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to place central venous access catheter using Surfacer system | performance evaluated by procedure time measured by time to create access | Procedure |
| Surfacer system advancement of the exit wire outside the vein |
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Inclusion Criteria: patients referred for placement of a central venous catheter
Exclusion Criteria:
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patients requiring central venous access for:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Minarsch, RT | Bluegrass Vascular | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vienna | Vienna | Waehringer Guertel 18-20 | A 1090 | Austria | ||
| University Hospital of Cologne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21237290 | Background | Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC. Inside-out access: a new method of lead placement for patients with central venous occlusions. Heart Rhythm. 2011 Jun;8(6):851-7. doi: 10.1016/j.hrthm.2011.01.024. Epub 2011 Jan 13. | |
| 24593804 | Background |
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Ability to advance system from femoral vein to supraclavicular exit as measured by time
| procedure |
| Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents | introducing a standard central venous access catheter over the needle wire | procedure |
| Cologne |
| D-50937 |
| Germany |
| Schon Klinik | Düsseldorf | 40549 | Germany |
| Azienda Ospedaliera San Carlo Borromeo | Milan | 20153 | Italy |
| Frykholm P, Pikwer A, Hammarskjold F, Larsson AT, Lindgren S, Lindwall R, Taxbro K, Oberg F, Acosta S, Akeson J. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2014 May;58(5):508-24. doi: 10.1111/aas.12295. Epub 2014 Mar 5. |
| 19595350 | Background | Baskin JL, Pui CH, Reiss U, Wilimas JA, Metzger ML, Ribeiro RC, Howard SC. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009 Jul 11;374(9684):159-69. doi: 10.1016/S0140-6736(09)60220-8. |