RecruitingNot ApplicableNCT06647017

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


Sponsor

University Surgical Vascular

Enrollment

40 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

DEVICEVolta tAN System

Transcutaneous auricular neurostimulation (tAN)

DEVICESHAM Volta tAN System

Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.


Locations(1)

University Surgical Vascular

Watkinsville, Georgia, United States

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NCT06647017


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