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Trial record 3 of 3 for:    bluegrass vascular

Evaluation of the Surfacer System Approach to Central Venous Access (SAVEUS)

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: NCT03209050
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Meditrial Europe Ltd.
Information provided by (Responsible Party):
Bluegrass Vascular Technologies

Brief Summary:
Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.

Condition or disease Intervention/treatment Phase
Venous Occlusion Device: Central Venous Access Placement Not Applicable

Detailed Description:
This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: patients requiring venous access
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Surfacer System Approach to Central Venous Access
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : June 1, 2019

Arm Intervention/treatment
Central Venous Access Placement
Central venous access placement
Device: Central Venous Access Placement
Device inserted into the femoral vein to insert a central venous access catheter




Primary Outcome Measures :
  1. Safe Insertion and patency of central venous access catheter [ Time Frame: up to 7 days ]
    safety


Secondary Outcome Measures :
  1. Safe use of the system to insert femoral vein to sub-clavicular exit as assessed by central venous access placement [ Time Frame: up to 7 days ]
    safety and efficacy



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
Criteria

Inclusion Criteria:

  • referred for placement of central venous access catheter
  • have limited or diminishing upper body venous access
  • have pathology impeding standard access methods
  • willing to give written informed consent

Exclusion Criteria:

  • occlusion of the right femoral vein
  • occlusion of the iliac vein
  • occlusion of the inferior vena cava
  • contraindicated by physician
  • acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous anatomy which precludes a straight line from femoral vein to subclavian
  • diagnosed with active pericarditis
  • diagnosed with active endocarditis
  • suspected pericardial effusion
  • known or suspected aneurysm or ectasia of ascending aorta
  • innominate artery or subclavian artery
  • pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study

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): NCT03209050


Locations
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United States, Texas
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bluegrass Vascular Technologies
Meditrial Europe Ltd.
Investigators
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Study Director: Monica Tocchi, MD Meditrial Europe Ltd.

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Responsible Party: Bluegrass Vascular Technologies
ClinicalTrials.gov Identifier: NCT03209050     History of Changes
Other Study ID Numbers: BVT.Surfacer.17-01
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes