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Study details
Enrolling now

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

SecondWave Systems Inc.
NCT IDNCT07163221ClinicalTrials.gov data as of Apr 2026
Target enrollment

60

Study length

about 1.1 years

Ages

18+

Locations

5 sites in AZ, CA, CO +1

What this study is about

Researchers are testing a device that delivers ultrasound stimulation to the spleen at home for people with rheumatoid arthritis who don't respond well to other treatments. The trial will last 392 days and involve two groups: one group receives active ultrasound stimulation, another receives sham (fake) ultrasound stimulation, and a third group receives no treatment. Participants are adults with moderate to severe RA.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Conventional Synthetic DMARD
  • 2.Use Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1
  • 3.Use Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2
  • +1 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
Remote / At-home

Some or all participation from home

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control), Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)

Body systems

Immune