Clincosm LogoSign in Get a demo

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Sponsor
TVA Medical Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02119845
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
8
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Endovascular AVF (EndoAVF)
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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 Names:
  • FLEX

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Italian Hospital Asuncion Paraguay 1001-1925

    Sponsors and Collaborators

    • TVA Medical Inc.

    Investigators

    • Principal Investigator: Adrian Ebner, MD, Italian Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TVA Medical Inc.
    ClinicalTrials.gov Identifier:
    NCT02119845
    Other Study ID Numbers:
    • FLEX-1-001
    First Posted:
    Apr 22, 2014
    Last Update Posted:
    Apr 22, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by TVA Medical Inc.
    Chronic kidney disease
    Arteriovenous fistula (AVF)
    Hemodialysis
    Vascular access
    Endovascular AVF (EndoAVF)
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Apr 22, 2014