Recruiting

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

University Surgical Vascular · with Spark Biomedical, Inc. · NCT06647017

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Status re-checked against ClinicalTrials.gov within the last 12 hours.

The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.

Being studied: Volta tAN System; SHAM Volta tAN System

Conditions: Blood Loss, Surgical

Copied from the official record. The study team makes the final decision at screening.

Show full 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

University Surgical Vascular
Watkinsville, GA 30677
Site contact: David Sailors, MD