Blood Loss, SurgicalNCT06647017
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
A study testing Volta tAN System in people with Blood Loss, Surgical, run by University Surgical Vascular at 1 site in United States.
Trial summary
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Volta tAN System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 15 Nov 2026
- Phase
- Interventional
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Surgical Vascular
Watkinsville, Georgia, 30677
David Sailors, MD
David Sailors, MD
About this study
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
Read the detailed description
This study is designed as a randomized, double-blind, sham-controlled, single-center, pilot clinical trial in which adults undergoing dialysis port placement procedures will be randomized 1:1 into one of two treatment groups:
Group 1: Active tAN + standard of care Group 2: Sham tAN + standard of care
Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy.
- Conditions
- Blood Loss, Surgical
- Being tested
- Volta tAN System, SHAM Volta tAN System
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, blood loss, transcutaneous auricular neurostimulation, tAN
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volta tAN SystemDevice
Also called Sparrow Ascent
Transcutaneous auricular neurostimulation (tAN)
SHAM Volta tAN SystemDevice
Also called Sparrow Ascent
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN + standard of care | Experimental | Participants randomized to the active group will have an earpiece applied and receive 30 minutes of active tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed. Receives: Device: Volta tAN System |
| Sham tAN + standard of care | Sham comparator | Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. These participants will receive 30 minutes of sham tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed. Receives: Device: SHAM Volta tAN System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Blood Loss
Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.
Measured: Throughout procedure
Secondary outcomes (2)
Surgery Time
Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups.
Measured: First incision to incision closure
Time to Hemostasis
Comparison of mean time to hemostasis in active tAN versus sham tAN groups.
Measured: From end of AV graft placement to beginning of surgical site closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start13 Nov 2024
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Surgical Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spark Biomedical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647017
- Sponsor's protocol ID
- 1983231
- Status last verified
- May 2026
- First submitted
- 4 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes