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ACTIVE NOT RECRUITING

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

NCT06076499 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DEVICE NTX100

Study Locations (6)

California

  • Mark J Buchfuhrer, MD Office — Downey
  • Sleep Medicine Specialists of California — San Ramon

Massachusetts

  • Neurocare, Inc. — Newton

Missouri

  • Clayton Sleep Institute — St Louis

Ohio

  • Ohio Sleep Medicine and Institute — Dublin

South Carolina

  • Bogan Sleep Consultants, LLC — Columbia

Trial Details

FieldValue
Enrollment Target 325 participants
Start Date 2023-11-15
Est. Completion 2026-12

Sponsor

Noctrix Health

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06076499

The ClinicalTrials.gov registry entry for NCT06076499 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noctrix Health, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Restless Legs Syndrome appearing as the primary indexed condition, and to 1 intervention — of which NTX100 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06076499 reports 6 study locations spanning 5 distinct geographic areas — top geographies include California, Massachusetts, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06076499 about?

NCT06076499 is a clinical study titled "A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS". 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.

What is the current status of trial NCT06076499?

This trial is currently active not recruiting. The enrollment target is 325 participants. The study started on 2023-11-15. Estimated completion is 2026-12.

What conditions does trial NCT06076499 study?

This clinical trial studies the following conditions: Restless Legs Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06076499?

The interventions under investigation include: NTX100 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06076499?

This trial is sponsored by Noctrix Health, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06076499 being conducted?

This trial has 6 study locations across California, Massachusetts, Missouri, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial