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Trial record 1 of 2 for:    FLEX-1
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A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

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ClinicalTrials.gov Identifier: NCT02119845
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):
TVA Medical Inc.

Study Description
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Brief Summary:
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease (CKD) Device: Endovascular AVF (EndoAVF) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endovascular AVF (EndoAVF)
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
 Device: Endovascular AVF (EndoAVF)
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
Other Name: FLEX


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 months ]
    The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.


Secondary Outcome Measures :
  1. Access Functionality [ Time Frame: 6 Months ]
    The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period.


Eligibility Criteria
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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:

  • Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
  • Adult (age >18 years old).
  • Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
  • Written informed consent obtained
Contacts and Locations
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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): NCT02119845


Locations
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Paraguay
Italian Hospital
Asuncion, Paraguay, 1001-1925
Sponsors and Collaborators
TVA Medical Inc.
Investigators
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Principal Investigator: Adrian Ebner, MD Italian Hospital
More Information
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Responsible Party: TVA Medical Inc.
ClinicalTrials.gov Identifier: NCT02119845    
Other Study ID Numbers: FLEX-1-001
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014
Keywords provided by TVA Medical Inc.:
Chronic kidney disease
Arteriovenous fistula (AVF)
Hemodialysis
Vascular access
Endovascular AVF (EndoAVF)
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency