Ultrasound-guided needle placement for dialysis fistulas and grafts
Ultrasound-Guided Power-Assisted Needle Insertion for Vascular Access Study
This will test an ultrasound-guided, power-assisted device to help clinicians place two needles into arteriovenous fistulas or grafts for adults on hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | X9, Inc. Industry-sponsored |
| Locations | 1 site (Tashkent) |
| Trial ID | NCT07548151 on ClinicalTrials.gov |
What this trial studies
This interventional study uses an ultrasound-guided, power-assisted needle insertion device to guide clinicians placing two needles into arteriovenous fistulas (AVF) or grafts (AVG) at the start of dialysis. Eligible adults must have a forearm or upper-arm AVF/AVG that is actively used and meet ultrasound criteria for diameter (8–12 mm) and depth (≤6 mm). The device is intended to assist the cannulator in locating the access and inserting needles while participants report pain using a validated scale. The trial is being conducted at a single site in Tashkent, Uzbekistan.
Who should consider this trial
Good fit: Adults (≥18 years) on hemodialysis with a forearm or upper-arm AVF or AVG that is actively used and meets ultrasound criteria (8–12 mm diameter and ≤6 mm depth), who can consent and report pain, are ideal candidates.
Not a fit: Patients with AVFs/AVGs that are too deep or too small, or with aneurysms, stenosis, thrombosis, stents, conditions interfering with ultrasound imaging, pregnant or breastfeeding individuals, and those under 18 are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could make cannulation more accurate, faster, and less painful, potentially reducing infiltration and other access complications.
How similar studies have performed: Previous studies have shown that ultrasound guidance improves vascular access success, but the specific use of a power-assisted guided insertion device for AVF/AVG cannulation is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males or non-pregnant, non-breastfeeding females ≥ 18 years of age * Presence of an AVG/AVF access site in the forearm or upper arm * AVF is actively used for dialysis treatment * AVF diameter is between 8 mm and 12mm, confirmed by ultrasound * AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound * Able to report their pain using a validated pain scale. * Able and willing to provide written informed consent. Exclusion Criteria: * Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF/AVG access site * Presence of a condition or impediment that may interfere with ultrasound imaging
Where this trial is running
Tashkent
- Site 1 — Tashkent, Uzbekistan (Recruiting)
Study contacts
- Study coordinator: Rachel Walsh
- Email: rwalsh@x9med.com
- Phone: (650) 472-0307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.