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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06814028
The ClinicalTrials.gov registry entry for NCT06814028 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (82% lower). The listed sponsor is Spark Biomedical, which has 13 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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