An interventional study of Needle placement with the Investigational Device and Needle Placement with SOC in Dialysis, Cannulation and Vascular Access, sponsored by X9, Inc.. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by X9, Inc. · Not applicable, Interventional, and Treatment
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).
This is a prospective, multicenter, randomized treatment sequence, crossover clinical investigation at up to three sites in Australia and New Zealand. Up to 35 participants will complete three sessions under each treatment condition (investigational device and SOC).
The investigational device is designed to supplement the traditional "look, listen, and feel" approach and to replace "blind" needle insertion for cannulation. The device is inserted under operator control using ultrasound guidance, with the aim of aligning the needle tip with the center of the target vessel and reducing reliance on blind cannulation.
X9, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Needle Placement with SOC
Device: Needle placement with the Investigational Device
Dialysis cannulation needle placement with the investigational device
Dialysis cannulation needle placement per SOC
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.
Time frame: 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.
Time frame: 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.
Time frame: At each of three investigational device cannulation sessions over 1 week
Cannulation Clinical Success Score (CCSS): Superiority
Superiority of the investigational device to SOC for the number of sessions achieving CCSS. Tested only if both co-primary endpoints (CCSS and pain) are met. Not required for the primary effectiveness endpoint.
Time frame: At each of six cannulation sessions over 2 weeks
Technical insertion success with blood flashback
The proportion of sessions in each group with successful blood flashback from both needles.
Time frame: At each of six cannulation sessions over 2 weeks
Successful initiation of hemodialysis
The proportion of sessions in each group with successful initiation of hemodialysis.
Time frame: At each of six cannulation sessions over 2 weeks
Successful completion of hemodialysis
The proportion of sessions in each group with successful completion of hemodialysis.
Time frame: At each of six cannulation sessions over 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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X9, Inc.