DialysisVA-ASSISTNCT07856095
A Study of a Device That Helps Place Dialysis Needles
A study testing Needle placement with the Investigational Device and Needle Placement with SOC in people with Dialysis and Cannulation, run by X9, Inc. at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dialysis, Cannulation, Vascular Access
- What is being tested?
- Needle placement with the Investigational Device and Needle Placement with SOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Australia2 sites
Barwon Health
Geelong
Suzannah Barker, +61 2 8317-5460, suzannah@mobius-cro.com
St. Vincent's Hospital
Melbourne
Suzannah Barker, +61 2 8317-5460, suzannah@mobius-cro.com
New Zealand1 site
Waikato Hospital
Hamilton
Suzannah Barker, +61 2 8317-5460, suzannah@mobius-cro.com
About this study
Official title: Prospective Evaluation of Device-Assisted Needle Insertion for Vascular Access Study
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).
Read the detailed description
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.
- Conditions
- Dialysis, Cannulation, Vascular Access
- Being tested
- Needle placement with the Investigational Device, Needle Placement with SOC
- Keywords
- dialysis cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle placement with the Investigational DeviceDevice
Dialysis cannulation needle placement with the investigational device
Needle Placement with SOCOther
Dialysis cannulation needle placement per SOC
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Cannulation | Active comparator | Not described Receives: Other: Needle Placement with SOC |
| Investigational Device Cannulation | Experimental | Not described Receives: Device: Needle placement with the Investigational Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At each of three investigational device cannulation sessions over 1 week
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At each of six cannulation sessions over 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants serve as their own control.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- X9, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856095
- Sponsor's protocol ID
- CP00004, CP00005
- Acronym
- VA-ASSIST
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Device-Assisted Needle Insertion for Vascular Access Study
- ClinicalTrials.gov ID
- NCT07856095
- Acronym / sponsor ID
- VA-ASSIST / CP00004, CP00005
- Conditions
- Dialysis, Cannulation, Vascular Access
- Keywords
- dialysis cannulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- X9, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Cannulation | Active comparator | Other: Needle Placement with SOC |
| Investigational Device Cannulation | Experimental | Device: Needle placement with the Investigational Device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle placement with the Investigational DeviceDialysis cannulation needle placement with the investigational device | Device | Investigational Device Cannulation |
| Needle Placement with SOCDialysis cannulation needle placement per SOC | Other | Standard of Care Cannulation |
Primary outcome
Cannulation Clinical Success Score (CCSS)
Time frame: At each of six cannulation sessions over 2 weeks
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.
Mean Insertion Pain (0-10 Numeric Rating Scale)
Time frame: At each of six cannulation sessions over 2 weeks
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.
Rate of serious adverse events (SAEs) related to the investigational device or procedure during the clinical investigation.
Time frame: At each of three investigational device cannulation sessions over 1 week
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.
4 secondary outcomes
Cannulation Clinical Success Score (CCSS): Superiority
Time frame: At each of six cannulation sessions over 2 weeks
Technical insertion success with blood flashback
Time frame: At each of six cannulation sessions over 2 weeks
Successful initiation of hemodialysis
Time frame: At each of six cannulation sessions over 2 weeks
Successful completion of hemodialysis
Time frame: At each of six cannulation sessions over 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle placement with the Investigational Device and Needle Placement with SOC in people with Dialysis and Cannulation, run by X9, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Walsh (9256839456, rwalsh@x9med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannulation Clinical Success Score (CCSS) (time frame: At each of six cannulation sessions over 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.