Actively Recruiting
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Led by University Surgical Vascular · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Surgical Vascular
Lead Sponsor
S
Spark Biomedical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether transcutaneous auricular neurostimulation (tAN) therapy can reduce the amount of blood lost during dialysis arteriovenous (AV) graft placement procedures. The study is a randomized, double-blind, sham-controlled pilot trial conducted at a single center, focusing on adults undergoing dialysis port placement using synthetic grafts. The goal is to better understand the potential impact of tAN therapy on surgical blood loss in this population. Participants will be randomly assigned to one of two groups: an active tAN therapy group receiving 30 minutes of stimulation immediately before their dialysis port placement, or a sham group receiving 30 minutes of a non-active therapy session. Both groups will continue to receive standard care during the procedure. The active or sham therapy involves wearing an earpiece for the 30-minute session, which is removed before surgery begins. During the trial, researchers will measure blood loss and blood markers before and during the procedure to assess the therapy's effects. Additional assessments include surgery duration and time to achieve hemostasis. Participants will be monitored closely throughout the procedure, with data collected to evaluate the average total blood loss. The study will run until November 2026, with participant involvement centered around the dialysis port placement visit and the immediate surgical period.
CONDITIONS
Brief Title
Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Participant has a BMI 60 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of dialysis port placement procedure
Participants receive 30 minutes of active or sham transcutaneous auricular neurostimulation (tAN) immediately prior to their dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure to assess the therapy's effect.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University Surgical Vascular
Watkinsville, Georgia, United States, 30677
Actively Recruiting
Research Team
D
David Sailors, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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