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Surfacer System to Facilitate Access in Venous Occlusions (SAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02875899
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : November 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bluegrass Vascular Technologies

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.

Condition or disease
Chronic Venous Thrombosis Venous Thrombosis Upper Extremity Venous Thrombosis Upper Extremity Superficial Veins

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Surfacer System to Facilitate Access in Venous Occlusions
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : October 4, 2018



Primary Outcome Measures :
  1. 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 :
  1. Ability to place central venous access catheter using Surfacer system [ Time Frame: Procedure ]
    performance evaluated by procedure time measured by time to create access

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients requiring central venous access for:

  • dialysis
  • chemotherapy nutrition
  • delivery of any pharmacological therapy
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875899


Locations
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Austria
University of Vienna
Vienna, Waehringer Guertel 18-20, Austria, A 1090
Germany
University Hospital of Cologne
Cologne, Germany, D-50937
Schon Klinik
Dusseldorf, Germany, 40549
Italy
Azienda Ospedaliera San Carlo Borromeo
Milan, Italy, 20153
Sponsors and Collaborators
Bluegrass Vascular Technologies
Investigators
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Study Director: Laura Minarsch, RT Bluegrass Vascular

Additional Information:

Publications:
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Responsible Party: Bluegrass Vascular Technologies
ClinicalTrials.gov Identifier: NCT02875899    
Other Study ID Numbers: CP0002
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases