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Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study]

NCT05417854 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-10-12

No results posted yet for this study

Summary

The research objective is to assess efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a pilot study.

Specific Aims:

* Measure RA disease activity and clinical metrics during and after an 8-week course of spleen-directed daily ultrasound treatments.
* Measure molecular correlates, including Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), cortisol and cytokine levels, of rheumatoid arthritis disease activity during spleen-directed daily ultrasound treatments.

Conditions

Interventions

DEVICE

Splenic Ultrasound

Daily ultrasound application to the spleen of approximately 18 minutes per day, 5 days per week for up to 8 weeks, in addition to standard clinical care.

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • DARPA (United States Department of Defense)

    collaborator UNKNOWN

  • SecondWave Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Erik Peterson, M.D. · University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2023-07-19
Completion
2023-09-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417854 on ClinicalTrials.gov