Volta System for Menorrhagia
Trial Summary
Will I have to stop taking my current medications?
No, you won't have to stop taking your current medications. The trial requires that you continue using your current medications and supplements consistently throughout the study.
What data supports the effectiveness of the treatment Transcutaneous Auricular Neurostimulation for menorrhagia?
Is the Volta System for Menorrhagia safe for humans?
How is the Volta System for Menorrhagia treatment different from other treatments?
The Volta System uses transcutaneous auricular neurostimulation, which involves applying a low-intensity electrical current to the ear to stimulate the vagus nerve. This method is unique because it is non-invasive and targets the nervous system, unlike traditional treatments that may involve medication or surgery.123511
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for women experiencing heavy menstrual bleeding without a known cause. Participants will be involved over three menstrual cycles, including one baseline cycle and two with daily neurostimulation treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Menstruation
Participants estimate blood loss using the PBAC and assess menstrual symptoms using the CMSS without active tAN treatment
Second Menstruation
Participants self-administer two 1-hour active tAN sessions daily and assess blood loss and quality of life
Third Menstruation
Participants self-administer a single 2-hour active tAN session daily and assess blood loss and quality of life
Follow-up
Participants complete a device satisfaction survey and exit the study
Treatment Details
Interventions
- Transcutaneous Auricular Neurostimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spark Biomedical, Inc.
Lead Sponsor
Five Liters, Inc.
Industry Sponsor