End Stage Renal Failure, HemodialysisACCESS 2NCT07548151
Guided Needle Insertion for Vascular Access
A study testing Ultrasound-Guided, Power-Assisted Needle Insertion in people with End Stage Renal Failure, Hemodialysis and Cannulation, run by X9, Inc. at 1 site in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis, Cannulation
- What is being tested?
- Ultrasound-Guided, Power-Assisted Needle Insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUzbekistan
- Study dates
- 14 Apr 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Power-Assisted Needle Insertion for Vascular Access Study
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
- Being tested
- Ultrasound-Guided, Power-Assisted Needle Insertion
- Keywords
- Vascular access, hemodialysis, cannulation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided, Power-Assisted Needle InsertionDevice
Device Intervention
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided, Power-Assisted Needle Insertion | Experimental | Device Arm Receives: Device: Ultrasound-Guided, Power-Assisted Needle Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start14 Apr 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure, HemodialysisStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participant serves as their own control.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- X9, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548151
- Sponsor's protocol ID
- CP-00002
- Acronym
- ACCESS 2
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Power-Assisted Needle Insertion for Vascular Access Study
- ClinicalTrials.gov ID
- NCT07548151
- Acronym / sponsor ID
- ACCESS 2 / CP-00002
- Conditions
- End Stage Renal Failure, Hemodialysis, Cannulation
- Keywords
- Vascular access, hemodialysis, cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- X9, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 23 Apr 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 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?
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participant serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided, Power-Assisted Needle Insertion | Experimental | Device: Ultrasound-Guided, Power-Assisted Needle InsertionDevice Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Ultrasound-Guided, Power-Assisted Needle InsertionDevice Intervention | Device | Ultrasound-Guided, Power-Assisted Needle Insertion |
Primary outcome
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.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided, Power-Assisted Needle Insertion in people with End Stage Renal Failure, Hemodialysis and Cannulation, run by X9, Inc. at 1 site in Uzbekistan.
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 7 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: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 week). 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 29 May 2026.