Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

October 27, 2023

Primary Completion Date

April 18, 2025

Study Completion Date

April 18, 2025

Conditions
Von Willebrand Disease, Type 1Heavy Menstrual Bleeding
Interventions
DEVICE

Volta System

The Volta System will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. During Second Menstruation, participants will self-administer 2, 1-hour sessions of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation.

Trial Locations (1)

75252

Five Liters, Dallas

All Listed Sponsors
collaborator

Spark Biomedical, Inc.

INDUSTRY

lead

Five Liters, Inc.

INDUSTRY

NCT06064851 - Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease | Biotech Hunter | Biotech Hunter