An interventional study of Volta System in Heavy Menstrual Bleeding, sponsored by Spark Biomedical, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Spark Biomedical, Inc. · Not applicable, Interventional, and Treatment
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Among 85 studies in Menorrhagia with a site in United States — 8 open to participants now, 10 under way, none of them phase 3. Menorrhagia · United States.
Among the 85 studies in Menorrhagia with a site in United States, this one is the 47th largest by enrollment of the 71 interventional ones that give a count, is one of 4 that started in 2025, is one of 26 with no phase, and was the 81st registered.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
Browse Menorrhagia studies →8 of the 85 studies in Menorrhagia with a site in United States are open now. Recruiting first, the newest first:
Alnylam Pharmaceuticals · Sites in United States, Germany, Netherlands and 3 more countries
Ages 16–45 · Women only
Spark Biomedical, Inc. · Sites in United States
Ages 14–45 · Women only
Oregon Health and Science University · Sites in United States
Ages 10–24 · Women only
University of Colorado, Colorado Springs · Sites in United States
Ages 18–40 · Women only
Channel Medsystems · Sites in United States
Ages 25+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Menorrhagia studies recruiting now, 4 (17%) set no upper age limit and 19 (83%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
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85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 5 · Phase 3 22 · Phase 4 16
First in 2001; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 95 across 149 interventional studies indexed under Menorrhagia.
Median enrollment 82 across the 71 interventional studies, 256 across the 14 observational. Of the 66 that completed or were terminated, 40 (61%) have results posted.
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43 of 85 have an industry lead sponsor. The 10 most frequent:
Spark Biomedical, Inc. is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Spark Biomedical, Inc. has 2 studies filed under Menorrhagia — fewer than ten, so there is no comparison to draw.
3 of the studies in Menorrhagia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07575308Alnylam PharmaceuticalsHMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB | 2027-06-30 |
| NCT07326722Spark Biomedical, Inc.Delivering tAN to Reduce HMB: The LUNA Study | 2027-08-31 |
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Among the 85 studies in Menorrhagia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
This study is designed as an open label, single arm, cross-over decentralized clinical 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) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled into the study over the course of three consecutive menstrual cycles.
During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC) daily throughout the duration of the menstruation phase of their menstrual cycle. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the Short-Form 36 (SF-36).
During the Second Menstruation, participants will self-administer two 1-hour active tAN sessions daily (once in the AM, once in the PM), beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.
During the Third Menstruation, participants will self-administer a single 2-hour active tAN session each day, beginning Day 1 of menstruation through the final day of menstruation. Blood loss will be assessed daily using the PBAC throughout the duration of menstruation. Quality of life will be assessed with the CMSS and SF-36 on the final day of menstruation.
In addition, a device satisfaction survey will be completed at the end of the study. Participants will exit the study after the final day of their third menstruation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (2 one-hour active tAN sessions daily) followed by Third Menstruation (1 two-hour active tAN session daily).
Device: Volta System
The Volta System will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. During the Second and Third Menstruations, participants will self-administer daily active tAN sessions Volta System Device beginning Day 1 of menstruation through the final day of menstruation.
Blood loss
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.
Time frame: Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)
Quality of life
Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.
Time frame: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
Duration and severity of dysmenorrhea
Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second and third menstruations (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.
Time frame: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)
Ran from Feb 2025 to primary completion in Sep 2025, 7 months.
Of 23 interventional studies with no phase under Menorrhagia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 35. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Spark Biomedical, Inc.