NCT02119845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

April 17, 2014

Last Update Submit

November 25, 2025

Conditions

Chronic Kidney Disease (CKD)

Keywords

Chronic kidney diseaseArteriovenous fistula (AVF)HemodialysisVascular accessEndovascular AVF (EndoAVF)

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.

    6 months

Secondary Outcomes (1)

  • Access Functionality

    6 Months

Study Arms (1)

Endovascular AVF (EndoAVF)

EXPERIMENTAL

The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.

Device: Endovascular AVF (EndoAVF)

Interventions

Endovascular AVF (EndoAVF)DEVICE

The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.

Also known as: FLEX
Endovascular AVF (EndoAVF)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Italian Hospital

Asunción, 1001-1925, Paraguay

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicArteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Officials

  • Adrian Ebner, MD

    Italian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 22, 2014

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

PA(1)