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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL

Official Title: A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix NTX100 TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome -

Brief 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.

Detailed Summary: This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings.
Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.
Sponsor: Noctrix Health, Inc.

Current Primary Outcome: Change from baseline (study entry) in IRLS total score at 1-year.

Original Primary Outcome: Change from baseline (study entry) in IRLS total score at 1-year.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Noctrix Health, Inc.

Dates:
Date Received: September 26, 2023
Date Started: November 15, 2023
Date Completion: November 15, 2023
Last Updated: December 08, 2023
Last Verified: December 01, 2023