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Earpiece zaps nerves to curb bleeding in dialysis surgery

NCT ID NCT06647017

Symptom relief Sponsor: University Surgical Vascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a device that gently stimulates a nerve in the ear can reduce blood loss during surgery to place a dialysis graft. Forty adults undergoing this procedure will be randomly assigned to receive either the active stimulation or a sham (inactive) device. Researchers will measure total blood loss, surgery time, and time to stop bleeding.

What this could mean

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

Active substance
Volta tAN System (Sparrow Ascent) - a device that delivers mild electrical stimulation to the ear
What this could lead to
If it works, this could give surgeons a simple, non-drug way to reduce bleeding during dialysis access surgery.
What could go wrong
This is a very small early study (40 people) testing a device for a short-term effect. The sham group may show similar results, and the device may not reduce blood loss meaningfully.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

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 to 75 years

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: * Participant is undergoing a dialysis port placement procedure using synthetic graft * Participant is between 18 and 75 years of age * Participant is English proficient * Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements Exclusion Criteria: * Participant has a BMI ≥ 40 * Participant is currently taking a platelet inhibitor medication * Participant has a history of epileptic seizures * Participant has a history of neurological diseases or traumatic brain injury * Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators * Participant has abnormal ear anatomy or ear infection present * Person of childbearing age, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study * Person who is pregnant or lactating * Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Hemorrhage

As listed by the trial registrant

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

Blood loss, surgical

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Surgical Vascular

    RECRUITING

    Watkinsville, Georgia, 30677, United States

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