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Procedure

Neurostimulation for Heavy Menstrual Bleeding (HMB/VWD Trial)

N/A

Recruiting

Led By Navid Khodaparast, PhD

Research Sponsored by Five Liters, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of von Willebrand Disease Type 1

Regularly menstruating female participants between 18-45 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

Awards & highlights

HMB/VWD Trial Summary

This trial aims to see if tAN can improve quality of life & reduce pain in those with von Willebrand Disease during their menstrual cycle.

Who is the study for?

This trial is for regularly menstruating women aged 18-45 with Type 1 von Willebrand Disease who experience heavy menstrual bleeding. Participants must have been on oral birth control for at least three months and agree to maintain their current medication regimen without starting new treatments or homeopathic remedies during the study.Check my eligibility

What is being tested?

The study tests if transcutaneous auricular neurostimulation (tAN) using the Volta System can help manage heavy menstrual bleeding, improve quality of life, and reduce pain in patients with von Willebrand Disease during their menstrual cycle.See study design

What are the potential side effects?

Potential side effects are not specified but may include discomfort or skin irritation at the site of stimulation. As this is a non-invasive treatment, fewer systemic side effects are expected compared to drug therapies.

HMB/VWD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with von Willebrand Disease Type 1.

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I am a woman aged 18-45 and have regular menstrual cycles.

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I have a history of heavy menstrual bleeding.

HMB/VWD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood loss during menses in von Willebrand Disease patients

Duration and severity of dysmenorrhea in von Willebrand Disease patients

Duration of menstruation in von Willebrand Disease patients

+1 more

HMB/VWD Trial Design

1Treatment groups

Experimental Treatment

Group I: Baseline Followed by Active tANExperimental Treatment1 Intervention

First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Five Liters, Inc.Lead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Navid Khodaparast, PhDPrincipal InvestigatorChief Science Officer

2 Previous Clinical Trials

41 Total Patients Enrolled

Melanie McWade, PhDStudy DirectorSenior Director of Clinical Operations

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to take part in this experiment?

"Eligibility criteria for this investigation necessitates individuals have von willebrand disease and are aged between 18 and 45. The trial is expected to include 10 participants in total."

Answered by AI

What is the total enrollment count for this research endeavor?

"Affirmative, the database hosted on clinicaltrials.gov confirms that this medical trial is currently enrolling participants. It was first listed on October 27th 2023 and most recently updated November 6th of the same year. The research project requires 10 individuals between a single site to take part in it."

Answered by AI

Is this medical experiment open to individuals younger than fifty years old?

"In adherence to the inclusion criteria, this clinical trial restricts participants to 18-45 years of age."

Answered by AI

Are there any available openings for prospective participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov details that this medical experiment, initially published on October 27th 2023, is presently enrolling participants. The research necessitates 10 individuals to be recruited from a singular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients

2023. "Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064851.

All > Von Willebrand Disease