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Recruiting Not applicable

Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures

NCT06647017 · tracked via the Priya Life Science USA tracker
Sponsor
University Surgical Vascular
Phase
Not applicable
Started
2024-11-13
Last updated
2026-05-08

Condition(s) studied

Blood Loss, Surgical

Investigational drug(s) / intervention(s)

Volta tAN SystemSHAM Volta tAN System

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)

FacilityCityRegionStatus
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.

View NCT06647017 on ClinicalTrials.gov ↗ ← All trials in the USA