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NCT06814028 · ClinicalTrials.gov registry record · NA
Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
A NA study of Heavy Menstrual Bleeding, sponsored by Spark Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06814028: Completed NA study of Heavy Menstrual Bleeding, sponsored by Spark Biomedical.
NCT06814028 is a NA study of Heavy Menstrual Bleeding that has completed, run by Spark Biomedical. The registered enrollment target is 40 participants, below the 221-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06814028, a NA study of Heavy Menstrual Bleeding, has completed, sponsored by Spark Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day.
Conditions Studied
Interventions
- DEVICE Volta System
Study Locations (1)
Texas
- Five Liters - DECENTRALIZED STUDY - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2025-09-24 |
| Phase | NA |
What the finished NCT06814028 record still lists
NCT06814028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 221-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Heavy Menstrual Bleeding appearing as the primary indexed condition, and to 1 intervention - of which Volta System is the first listed.
NCT06814028 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06814028 about?
NCT06814028 is a clinical study titled "Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding 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)...
What is the current status of trial NCT06814028?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2025-02-14. Estimated completion is 2025-09-24.
What conditions does trial NCT06814028 study?
This clinical trial studies the following conditions: Heavy Menstrual Bleeding.
What interventions are being tested in trial NCT06814028?
The interventions under investigation include: Volta System (DEVICE).
Who is sponsoring clinical trial NCT06814028?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06814028 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heavy Menstrual Bleeding
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06814028's enrollment target sits among peer trials
40 7th of 9 higher than 3 of 9 other Heavy Menstrual Bleeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heavy Menstrual Bleeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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