Chronic Kidney Disease (CKD)NCT02119845
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
A study testing Endovascular AVF (EndoAVF) in people with Chronic Kidney Disease (CKD), run by C. R. Bard at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Endovascular AVF (EndoAVF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteParaguay
- Study dates
- Aug 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Endovascular AVF (EndoAVF)
- Keywords
- Chronic kidney disease, Arteriovenous fistula (AVF), Hemodialysis, Vascular access, Endovascular AVF (EndoAVF)
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular AVF (EndoAVF)Device
Also called FLEX
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular AVF (EndoAVF) | Experimental | The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access. Receives: Device: Endovascular AVF (EndoAVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
Measured: 6 months
Secondary outcomes (1)
Access Functionality
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Italian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119845
- Sponsor's protocol ID
- FLEX-1-001
- Status last verified
- Nov 2025
- First submitted
- 17 Apr 2014
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001
- ClinicalTrials.gov ID
- NCT02119845
- Acronym / sponsor ID
- FLEX-1-001
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Chronic kidney disease, Arteriovenous fistula (AVF), Hemodialysis, Vascular access, Endovascular AVF (EndoAVF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular AVF (EndoAVF) | Experimental | Device: Endovascular AVF (EndoAVF)The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular AVF (EndoAVF)Also: FLEXThe FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access. | Device | Endovascular AVF (EndoAVF) |
Primary outcome
Adverse Events
Time frame: 6 months
The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
1 secondary outcome
Access Functionality
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Ebner, MD principal investigator
Italian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular AVF (EndoAVF) in people with Chronic Kidney Disease (CKD), run by C. R. Bard at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.