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
- 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 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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
- ClinicalTrials.gov ID
- NCT06647017
- Acronym / sponsor ID
- 1983231
- Conditions
- Blood Loss, Surgical
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, blood loss, transcutaneous auricular neurostimulation, tAN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Surgical VascularIndustry (pharma, biotech, devices)
- Collaborators
- Spark Biomedical, Inc.
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 17 Oct 2024 (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 objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tAN + standard of care | Experimental | Device: Volta tAN SystemParticipants 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. |
| Sham tAN + standard of care | Sham comparator | Device: SHAM Volta tAN SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Volta tAN SystemAlso: Sparrow AscentTranscutaneous auricular neurostimulation (tAN) | Device | Active tAN + standard of care |
| SHAM Volta tAN SystemAlso: Sparrow AscentParticipants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. | Device | Sham tAN + standard of care |
Primary outcome
Mean Total Blood Loss
Time frame: Throughout procedure
Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.
2 secondary outcomes
Surgery Time
Time frame: First incision to incision closure
Time to Hemostasis
Time frame: From end of AV graft placement to beginning of surgical site closure
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 8 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volta tAN System in people with Blood Loss, Surgical, run by University Surgical Vascular at 1 site in United States.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 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 United States. 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. Some participants in this study may receive a placebo. 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 David Sailors, MD ((706) 549-8306, dsailors@gasurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Blood Loss (time frame: Throughout procedure). 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 8 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.