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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Surgical Vascular

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Volta tAN System
  • SHAM Volta tAN System

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Surgical Vascular

Lead sponsor

Spark Biomedical, Inc.

Collaborator