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

November 25, 2025 updated by: C. R. Bard

A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Paraguay
      • Asunción, Paraguay, 1001-1925
        • Italian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: Adrian Ebner, MD, Italian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimated)

April 22, 2014

Study Record Updates

Last Update Posted (Estimated)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLEX-1-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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