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

NCT06647017 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Blood Loss, Surgical

Interventions

DEVICE

Volta tAN System

Transcutaneous auricular neurostimulation (tAN)

DEVICE

SHAM Volta tAN System

Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.

Sponsors & Collaborators

  • Spark Biomedical, Inc.

    collaborator INDUSTRY

  • University Surgical Vascular

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2026-11-15
Completion
2026-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647017 on ClinicalTrials.gov