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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-02-28

Brief Summary

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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) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.

Detailed Description

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Conditions

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Chronic Kidney Disease (CKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Endovasccular AVF (EndoAVF)

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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FLEX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Paraguay

Other Identifiers

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FLEX-1-002-IR

Identifier Type: -

Identifier Source: org_study_id

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