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New device aims to make dialysis needle sticks easier

NCT ID NCT07548151

Symptom relief Sponsor: X9, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device that uses ultrasound to help guide needles into the blood vessels of people with end-stage kidney disease who need dialysis. Ten adults with an arteriovenous fistula or graft took part. The main goal was to see if the device could help place needles successfully within three tries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ultrasound-guided power-assisted needle insertion device
What this could lead to
If it works, this device could make dialysis needle insertion easier and more reliable for patients with kidney failure.
What could go wrong
This is a very small, early study with only 10 participants, so results may not apply to everyone. The device may not improve success rates or could cause discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Apr 2026

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cannulation End stage renal failure, hemodialysis

Contacts and locations

Locations

  • Site 1

    Tashkent, Uzbekistan

More trials for these conditions

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