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

Launched by UNIVERSITY SURGICAL VASCULAR · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transcutaneous auricular neurostimulation (tAN) to see if it can help reduce blood loss during a specific type of surgery known as dialysis AV graft placement. This procedure involves creating an access point for dialysis in patients with kidney issues. The goal of the trial is to find out if this therapy can make the surgery safer by minimizing the amount of blood lost during the process.

To participate in this trial, individuals need to be between 18 and 75 years old and must be scheduled for a dialysis port placement using a synthetic graft. They should be able to understand English and provide informed consent, which means they can agree to participate after understanding what the study involves. However, there are some reasons that might exclude someone from joining the trial, such as having a high body weight, certain medical conditions, or specific medical devices in their body. Participants in the trial will receive the tAN therapy during their procedure and will be monitored to see how well it works in reducing blood loss. This study is not yet recruiting, so individuals interested in participating will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• 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