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

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

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Device: Volta tAN System; Device: SHAM Volta tAN System

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Sailors, MD; Phone Number: (706) 549-8306; Email: dsailors@gasurgery.com

Study Locations

• United States
  • Georgia
    • Watkinsville, Georgia, United States, 30677
      • Recruiting
      • University Surgical Vascular
      • Contact: David Sailors, MD
      • Principal Investigator: David Sailors, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tAN + standard of care; Participants randomized to the active group will have an earpiece applied and receive 30 minutes of active tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed.	Device: Volta tAN System; Transcutaneous auricular neurostimulation (tAN); Other Names: Sparrow Ascent
Sham Comparator: Sham tAN + standard of care; Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. These participants will receive 30 minutes of sham tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed.	Device: SHAM Volta tAN System; Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.; Other Names: Sparrow Ascent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Total Blood Loss	Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.	Throughout procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Time	Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups.	First incision to incision closure
Time to Hemostasis	Comparison of mean time to hemostasis in active tAN versus sham tAN groups.	From end of AV graft placement to beginning of surgical site closure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostatic Agent Use	Proportion of participants requiring hemostatic agents	During surgery
Duration of time between completing graft placement and application/administration of hemostatic agent	Duration of time between completing graft placement and application/administration of hemostatic agent	During surgery
Proportion of participants achieving hemostasis in <10 minutes	Proportion of participants achieving hemostasis in <10 minutes	During surgery
Blood Assay Results	Blood urea nitrogen (BUN) levels, platelet count, hematocrit, and activated clotting time (ACT)	Prior to device placement, during surgery, and at end of surgery
Treatment-Related Adverse Events (Safety)	The proportion of participants who experience one or more treatment-related adverse events.	Thorough study completion, an average of 4 hours

Collaborators and Investigators

• Sponsor: University Surgical Vascular
• Collaborators: Spark Biomedical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: blood loss; vagus nerve stimulation; auricular neurostimulation; transcutaneous; transcutaneous auricular neurostimulation; tAN
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: 1983231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No