A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
NCT ID: NCT02119832
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2013-04-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endovascular AVF (EndoAVF)
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access
Endovasccular AVF (EndoAVF)
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access
Interventions
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Endovasccular AVF (EndoAVF)
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult (age \>18 years old).
* Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
* Written informed consent obtained
18 Years
80 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Ebner, MD
Role: PRINCIPAL_INVESTIGATOR
Italian Hosptial, Asuncion, Paraguay
Locations
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Italian Hospital
Asunción, , Paraguay
Countries
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Other Identifiers
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FLEX-1-002-IR
Identifier Type: -
Identifier Source: org_study_id
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