An interventional study of Endovascular AVF (EndoAVF) in Chronic Kidney Disease (CKD), sponsored by C. R. Bard. Completed at 1 site in Paraguay. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 16 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.
First submitted before C. R. Bard became part of Becton, Dickinson and Company.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: FLEX
Adverse Events
The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
Time frame: 6 months
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.
Time frame: 6 Months
The record gives a start of Aug 2012, a primary completion of Apr 2013 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →