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Compares treatment options for End Stage Renal Disease on Dialysis
Official title Comparing Surgical and Endovascular Arteriovenous Fistula Creation
ClinicalTrials.gov ID: NCT05654103
What this study is testing
- What it's testing
- Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
- Ability to give consent to participate in a research study.
- Upper arm vein diameter of ≥ 2.0 mm. Ellipsys specific
- Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed...
- Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects. WavelinQ specific
You likely can't join if
- People under the age of 18.
- Inability to understand the consent process and/or give consent.
- Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
- Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a...
- Currently incarcerated individuals.
- Currently pregnant or planning to get pregnant within the next 6 months.
See the full eligibility criteria
- ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
- Ability to give consent to participate in a research study.
- Upper arm vein diameter of ≥ 2.0 mm. Ellipsys specific
- Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.
- Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects. WavelinQ specific
- Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.
- People under the age of 18.
- Inability to understand the consent process and/or give consent.
- Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
- Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve...
- Currently incarcerated individuals.
- Currently pregnant or planning to get pregnant within the next 6 months.
- Individuals who choose peritoneal dialysis over hemodialysis and/or undergoing a kidney transplant within 6 months of randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.