Condition: Rheumatoid Arthritis (RA) · Sponsor: SecondWave Systems Inc.
The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.
This description comes directly from the study's public registry record.
Daniel Zachs · 612-444-6264 · info@secondwaveus.com
Always discuss trial participation with your own doctor first.
| Arizona Arthritis and Rheumatology Associates P.C. | Glendale, Arizona, United States | Active Not Recruiting |
| Medvin Clinical Research | Covina, California, United States | Active Not Recruiting |
| Southland Arthritis & Osteoporosis Medical Center | Temecula, California, United States | Active Not Recruiting |
| University of Colorado | Aurora, Colorado, United States | Active Not Recruiting |
| University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases | Minneapolis, Minnesota, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07163221