Recruiting

tAN Therapy

Sponsor:

University Surgical Vascular

Code:

NCT06647017

Conditions

Blood Loss, Surgical

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Volta tAN System

SHAM Volta tAN System

Study Details

Brief 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.

Conditions

Blood Loss, Surgical

Study ID

NCT06647017

Start date

Nov 13, 2024

Status verified date

May, 2026

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tAN + standard of care

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.

sham comparator: Sham tAN + standard of care

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.

Interventions

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.

Primary outcome measure

  • Mean Total Blood Loss [ Time Frame: Throughout procedure ]

Central Contacts and Locations

Central contacts

David Sailors, MD

(706) 549-8306dsailors@gasurgery.com

Locations

University Surgical Vascular

Recruiting

Watkinsville, Georgia, United States, 30677

Principal Investigator:

David Sailors, MD

More Information

Sponsor

University Surgical Vascular

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • auricular neurostimulation
  • vagus nerve stimulation
  • transcutaneous
  • blood loss
  • transcutaneous auricular neurostimulation
  • tAN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Surgical Vascular on 2026-05-08.