BD WavelinQ EndoAVF System for Kidney Disease
This study is looking at how well the BD® WavelinQ™ EndoAVF System works for people with kidney disease who need dialysis. This system helps create an arteriovenous (AV) fistula, which is a connection between an artery and a vein, usually in the arm, to make dialysis easier. You might be able to join if you are at least 18 years old and have kidney disease requiring dialysis. The study will check if the fistula works well for dialysis (functional cannulation success) and stays open (primary patency) after 6 months. It will also look at any serious problems related to the device or procedure within 30 days. The current recruitment status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the same intervention. It plans to enroll 280 participants.
- What's involved
- You will have an endoAVF created using the WavelinQ EndoAVF System.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 6 months after the procedure to check how well the fistula works.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
At a glance
Conditions
Where it's being run
17 sites across 10 statesStudy leadership
- Eric Peden, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
- Paul Kreienberg, MD · PRINCIPAL_INVESTIGATOR · Albany Medical College
Who to contact
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What this trial measures
- Functional Cannulation Success6-months post index procedure
The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period
- Primary Patency6-months post index procedure
Subjects maintaining primary patency of the endoAVF
- Device- and procedure-related serious adverse events (SAE)30-days post index procedure
Freedom from device-related or procedure-related SAEs