Volta tAN System: Transcutaneous auricular neurostimulation (tAN)
SHAM Volta tAN System: Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Mean Total Blood Loss — Throughout procedure Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.
Trial sites (1)
Facility
City
Region
Status
University Surgical Vascular
Watkinsville
Georgia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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