Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 14, 2025

Primary Completion Date

September 24, 2025

Study Completion Date

September 24, 2025

Conditions
Heavy 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 the Second and Third Menstruations, participants will self-administer daily active tAN sessions Volta System Device beginning Day 1 of menstruation through the final day of menstruation.

Trial Locations (1)

75252

Five Liters - DECENTRALIZED STUDY, Dallas

All Listed Sponsors
collaborator

Five Liters, Inc.

INDUSTRY

lead

Spark Biomedical, Inc.

INDUSTRY

NCT06814028 - Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial | Biotech Hunter | Biotech Hunter