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Study details
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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants 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
Primary goalChange in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low12%
Logistics
High100%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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