A Study of a Device That Helps Place Dialysis Needles

NCT07856095 | Not Yet Recruiting FDA Device

• 1 other identifier: CP00004, CP00005
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the X9 Ultrasound System with Power-Assisted Needle Insertion, an investigational device, compared with standard of care (SOC) cannulation for placing haemodialysis needles in an arteriovenous fistula (AVF) or arteriovenous graft (AVG).

Conditions

Dialysis; Cannulation; Vascular Access

Keywords

dialysis cannulation

Outcome Measures

Primary Outcomes (3)

• Cannulation Clinical Success Score (CCSS)

  Co-primary endpoint. CCSS is achieved when haemodialysis is successfully started without additional needle puncture, needle repositioning or redirection, or infiltration. For each participant, the number of sessions achieving CCSS (out of three per treatment condition) is compared between the investigational device and standard of care (SOC). The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.

  At each of six cannulation sessions over 2 weeks

• Mean Insertion Pain (0-10 Numeric Rating Scale)

  Co-primary endpoint. Participants rate pain for each needle insertion on a 0-10 scale (0 = no pain, 10 = worst pain possible). Each participant's mean pain score with the investigational device is compared with their mean pain score with SOC. The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.

  At each of six cannulation sessions over 2 weeks

• Rate of serious adverse events (SAEs) related to the investigational device or procedure during the clinical investigation.

  Each participant will be a safety endpoint failure if the participant has SAEs related to the investigational device or procedure, otherwise the participant will be a primary safety endpoint success.

  At each of three investigational device cannulation sessions over 1 week

Secondary Outcomes (4)

• Cannulation Clinical Success Score (CCSS): Superiority

  At each of six cannulation sessions over 2 weeks

• Technical insertion success with blood flashback

  At each of six cannulation sessions over 2 weeks

• Successful initiation of hemodialysis

  At each of six cannulation sessions over 2 weeks

• Successful completion of hemodialysis

  At each of six cannulation sessions over 2 weeks

Study Arms (2)

Standard of Care Cannulation

ACTIVE COMPARATOR

Other: Needle Placement with SOC

Investigational Device Cannulation

EXPERIMENTAL

Device: Needle placement with the Investigational Device

Interventions

Needle placement with the Investigational Device DEVICE

Dialysis cannulation needle placement with the investigational device

Investigational Device Cannulation

Needle Placement with SOC OTHER

Dialysis cannulation needle placement per SOC

Standard of Care Cannulation

Eligibility Criteria

• Age: 21 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 ≥ 21 years of age
• Receiving facility-based (in-center) haemodialysis
• Presence of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) in the arm.
• AVF/AVG is actively used for haemodialysis treatment.
• AVF/AVG diameter between 6 mm and 12 mm, confirmed by ultrasound.
• AVF/AVG is ≤6 mm below the surface of the skin, confirmed by ultrasound.
• Able to complete the study questionnaires.
• Able and willing to provide written informed consent.

You may not qualify if:

• Presence of known stents in the cannulation zone of the AVF/AVG access site
• Presence of a condition or impediment that may interfere with ultrasound imaging

Sponsors & Collaborators

• X9, Inc.: lead

Study Sites (3)

Barwon Health

Geelong, Australia

Location

St. Vincent's Hospital

Melbourne, Australia

Location

Waikato Hospital

Hamilton, New Zealand

Location

Central Study Contacts

Rachel Walsh

CONTACT

9256839456; rwalsh@x9med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants serve as their own control.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

AU (2); NZ (1)