Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT05654103
Eligibility Criteria:
Inclusion 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 inclusion criteria:
* 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 inclusion criteria:
* Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.
Exclusion Criteria:
* 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 more proximal anatomic sites for future accesses.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05654103
Study Brief:
Protocol Section:
NCT05654103