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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

November 30, 2026

Conditions
Rheumatoid Arthritis (RA)
Interventions
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

Trial Locations (1)

55455

RECRUITING

University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases, Minneapolis

All Listed Sponsors
lead

SecondWave Systems Inc.

INDUSTRY