RecruitingNot ApplicableNCT07163221

At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]

Sponsor

SecondWave Systems Inc.

Enrollment

60 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a device that delivers low-intensity focused ultrasound to specific joints at home to treat rheumatoid arthritis (RA) — a condition where the immune system attacks the joints causing pain, swelling, and stiffness. The device is used alongside existing medications. **You may be eligible if...** - You are 18 or older - You have moderate to severe seropositive RA (confirmed by blood markers) - You have at least 6 tender or swollen joints - Your current arthritis medications haven't worked well enough - You are already on a stable dose of a conventional RA medication (such as methotrexate) **You may NOT be eligible if...** - You have an implanted electronic device such as a pacemaker - You have an active joint infection - You have recently started a new biologic RA medication - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENon-invasive ultrasound stimulation of the spleen - Treatment Setting 1

Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day

DEVICENon-invasive ultrasound stimulation of the spleen - Treatment Setting 2

Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day

DEVICESham ultrasound stimulation (control)

Sham ultrasound stimulation for 20 minutes once per day

DRUGConventional Synthetic DMARD

All subjects will take at least one type of conventional synthetic DMARD at the same stable dose for at least 8 weeks prior to the treatment period and continuing through study close out

Locations(5)

Arizona Arthritis and Rheumatology Associates P.C.

Glendale, Arizona, United States

Medvin Clinical Research

Covina, California, United States

Southland Arthritis & Osteoporosis Medical Center

Temecula, California, United States

University of Colorado

Aurora, Colorado, United States

University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases

Minneapolis, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT07163221

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