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NCT06814028
Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
NA trial testing Volta System in Heavy Menstrual Bleeding in 40 participants. Completed in 24 September 2025.
24 September 2025
Quick facts
| Lead sponsor | Spark Biomedical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 14 February 2025 |
| Primary completion | 24 September 2025 |
| Estimated completion | 24 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Volta System
Conditions studied
- Heavy Menstrual Bleeding — all drugs for Heavy Menstrual Bleeding →
Sponsor
Spark Biomedical, Inc.
Who can join
Adults 18 to 45, female only, with Heavy Menstrual Bleeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A novel transcutaneous auricular neurostimulation electrode configuration for treatment of heavy menstrual bleeding: an open-label trial.
Czura CJ, Weyand AC, Baldwin MK, Recht M, et al · · 2026 · PMID 41933398 · DOI 10.1186/s42234-026-00203-1
Verify or expand the search:
- PubMed search for NCT06814028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Volta System
Trials testing the same drug.
- NCT05977946 — Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects · NA · completed
- NCT06064851 — Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von · NA · completed
Other recruiting trials for Heavy Menstrual Bleeding
Currently open trials in the same condition.
- NCT07326722 — Delivering tAN to Reduce HMB: The LUNA Study · NA · recruiting
- NCT06634719 — Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB) · NA · recruiting
- NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids · Phase 3 · recruiting
- NCT05922657 — A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device · recruiting
- NCT06921629 — Menstrual Complaints in Adolescents and Adults · active not recruiting
Other Spark Biomedical, Inc. trials
Trials by the same sponsor.
- NCT07326722 — Delivering tAN to Reduce HMB: The LUNA Study · NA · recruiting
- NCT07281261 — tAN for Substance Use Disorder · NA · recruiting
- NCT07109349 — tAN for First Responders · NA · recruiting
- NCT06487533 — Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder · recruiting
- NCT06390267 — Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress React · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06814028 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spark Biomedical, Inc.
- Last refreshed: 26 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06814028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing