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

ClinicalTrials.gov ID: NCT07163221

Public ClinicalTrials.gov record NCT07163221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07163221
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: SecondWave Systems Inc.; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Rheumatoid Arthritis (RA)

Interventions

Device · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2, 2025
Primary completion: Jul 31, 2026
Completion: Oct 31, 2026
Last update posted: Jun 16, 2026

2025 – 2026

United States locations

U.S. sites: 5
U.S. states: 4
U.S. cities: 5

Facility	City	State	ZIP	Site status
Arizona Arthritis and Rheumatology Associates P.C.	Glendale	Arizona	85306	Active, not recruiting
Medvin Clinical Research	Covina	California	91722	Active, not recruiting
Southland Arthritis & Osteoporosis Medical Center	Temecula	California	92592	Active, not recruiting
University of Colorado	Aurora	Colorado	80045	Active, not recruiting
University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases	Minneapolis	Minnesota	55455	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07163221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 16, 2026 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07163221 live on ClinicalTrials.gov.

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