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A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS

Study acronym: THRIVE
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated May 27, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 6 to 7v9
  2. Primary completion date: Dec 2025 to Jul 2026
    • Study completion date: Dec 2026 to Jul 2027
    • Study title expanded, about 1 word
    v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 2025 to Dec 2025
    • Site details revised at 6 of 6 sites
    v7
  4. Eligibility criteria shortened, about 119 words
    • Study sites revised (6)
    v6
  5. Site details revised at 1 of 6 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 4 to 6v4
  2. Study sites: 1 to 4v3
  3. Primary completion date: Jun 2024 to Jun 2025
    • Study completion date: Dec 2025 to Dec 2026
    • Start date changed from estimate of Oct 10, 2023 to Nov 15, 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.
Trial Details
NCT Number NCT06076499
Lead Sponsor Noctrix Health, Inc.
Conditions
(from sponsor)		 Restless Legs Syndrome
Related terms Restless Legs Syndrome
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov