NCT06647017

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Surgical Vascular · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Loss, Surgical

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-05-01
• Completion: 2025-05-31
• First posted: 2024-10-17
• Last updated: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study