Guided Needle Insertion for Vascular Access

NCT07548151 | Recruiting

• 1 other identifier: CP-00002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment. Males or females with end-stage kidney disease who are 18 and older and not pregnant or breastfeeding can be included in the study. The main question it aims to answer is: Can the study device guide the cannulator to the arteriovenous fistula (AVF) or arteriovenous graft (AVG) and assist the cannulator with needle insertion into the AVF or AVG for dialysis cannulation?

Conditions

End Stage Renal Failure, Hemodialysis; Cannulation

Keywords

Vascular access; hemodialysis; cannulation

Outcome Measures

Primary Outcomes (1)

• Proportion of investigational device cannulations in which successful cannulation of the AVF/AVG is achieved within a maximum of three attempts, confirmed by blood flashback and ability to proceed with dialysis.

  1 week

Study Arms (1)

Ultrasound-Guided, Power-Assisted Needle Insertion

EXPERIMENTAL

Device Arm

Device: Ultrasound-Guided, Power-Assisted Needle Insertion

Interventions

Ultrasound-Guided, Power-Assisted Needle Insertion DEVICE

Device Intervention

Ultrasound-Guided, Power-Assisted Needle Insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• X9, Inc.: lead

Study Sites (1)

Site 1

Tashkent, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rachel Walsh

CONTACT

(650) 472-0307; rwalsh@x9med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participant serves as their own control.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)