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First Evaluation of a Craniofacial Nerve Stimulation System in Chronic Migraine

Study acronym: SalviaBio
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Dec 31, 2026 to Dec 31, 2027 Study title shortened, about 1 wordv8 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Completion date: Jan 31, 2026 to Dec 31, 2026v7
  3. Re-verified, no change to tracked fieldsv6
  4. Completion date: Dec 31, 2024 to Jan 31, 2026v5
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 6 to confirmed 7 · Primary completion date: Oct 1, 2023 to Dec 9, 2023 · Site details revisedv4 Show 3 more changesShow less
    • Enrollment target: estimated 6 to confirmed 7
    • Primary completion date: Oct 1, 2023 to Dec 9, 2023
    • Site details revised
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  1. Enrollment target: 5 to 6 Completion date: Jan 31, 2024 to Dec 31, 2024 · Eligibility criteria shortened, about 2 wordsv3 Show 2 more changesShow less
    • Completion date: Jan 31, 2024 to Dec 31, 2024
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary endpoints: 1 to 2 · Site details revisedv2 Show 2 more changesShow less
    • Primary endpoints: 1 to 2
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.
Trial Details
NCT Number NCT05858801
Lead Sponsor Salvia BioElectronics
Conditions Chronic Migraine
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov