Access Cannulation Trial II for Dialysis Patients
This study is testing a device called VenaSure, which is surgically implanted at the access site for patients undergoing routine hemodialysis (a treatment that filters waste and water from your blood). The goal is to see if the VenaSure device helps make it easier to cannulate (insert needles into) arteriovenous fistulas (AVFs) for dialysis over the long term. Researchers will also be looking at how safe the device is. You might be able to join if you are 18 or older, and your AVF is difficult to cannulate because it's deeper than 6mm from your skin's surface. The study aims to enroll 100 participants and is currently unclear about its recruitment status.
- Study design
- This is a single-arm, open-label study, meaning all participants will receive the VenaSure device, and everyone will know what treatment is being given. It plans to include 100 participants.
- What's involved
- After the VenaSure device is implanted, you will be observed for 6 weeks as the site heals. You will then be monitored for 36 months during your routine dialysis treatments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for 36 months after the device is implanted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Access Cannulation Trial II
At a glance
Conditions
Where it's being run
8 sites across 7 statesStudy leadership
- Stephen Hohmann, MD · PRINCIPAL_INVESTIGATOR · Baylor Scott and White Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.6 months
Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.
- To evaluate the safety of the study device.12 months
The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, complicated seroma) during a 12- month follow-up period from initial implantation adjudicated by a Data Monitoring Committee (DMC)