Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Start Date
11/13/2024
Completion Date
11/15/2026
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.
Detailed Description
This study is designed as a randomized, double-blind, sham-controlled, single-center, pilot clinical trial in which adults undergoing dialysis port placement procedures will be randomized 1:1 into one of two treatment groups: Group 1: Active tAN + standard of care Group 2: Sham tAN + standard of care Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Volta tAN System
SHAM Volta tAN System
Conditions
Locations
University Surgical Vascular
Watkinsville, Georgia 30677
United States