NCT07163221

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: SecondWave Systems Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DEVICE	Non-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
DEVICE	Non-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
DEVICE	Sham ultrasound stimulation (control)	Sham ultrasound stimulation for 20 minutes once per day
DRUG	Conventional 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

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-09-09
• Last updated: 2026-02-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study