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

NCT06814028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-26

No results posted yet for this study

Summary

This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.

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.

Sponsors & Collaborators

  • Five Liters, Inc.

    collaborator INDUSTRY

  • Spark Biomedical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2025-09-24
Completion
2025-09-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06814028 on ClinicalTrials.gov