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NCT07163221 · ClinicalTrials.gov registry record · NA
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
A NA study of Rheumatoid Arthritis (RA), sponsored by SecondWave Systems.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT07163221 is a NA study of Rheumatoid Arthritis (RA) that is actively recruiting participants, run by SecondWave Systems. The registered enrollment target is 60 participants, below the 264-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (77% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT07163221, a NA study of Rheumatoid Arthritis (RA), is actively recruiting participants, sponsored by SecondWave Systems.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study 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 Studied
Interventions
- DEVICE Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1
- DEVICE Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2
- DEVICE Sham ultrasound stimulation (control)
- DRUG Conventional Synthetic DMARD
Study Locations (5)
California
- Medvin Clinical Research - Covina
- Southland Arthritis & Osteoporosis Medical Center - Temecula
Arizona
- Arizona Arthritis and Rheumatology Associates P.C. - Glendale
Colorado
- University of Colorado - Aurora
Minnesota
- University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-03 |
| Est. Completion | 2026-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07163221
The ClinicalTrials.gov registry entry for NCT07163221 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 264-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (77% lower). The listed sponsor is SecondWave Systems, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis (RA) appearing as the primary indexed condition, and to 4 interventions - of which Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1 is the first listed.
NCT07163221 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT07163221 about?
NCT07163221 is a clinical study titled "At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]". 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 DMA...
What is the current status of trial NCT07163221?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-11-03. Estimated completion is 2026-11.
What conditions does trial NCT07163221 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis (RA).
What interventions are being tested in trial NCT07163221?
The interventions under investigation include: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1 (DEVICE), Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2 (DEVICE), Sham ultrasound stimulation (control) (DEVICE), Conventional Synthetic DMARD (DRUG).
Who is sponsoring clinical trial NCT07163221?
This trial is sponsored by SecondWave Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07163221 being conducted?
This trial has 5 study locations across Arizona, California, Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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