NCT03690466

Ultrasound Treatment of Rheumatoid Arthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The research objective of the pilot study is to assess early feasibility of safety and efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a blinded and randomized controlled trial. Specific Aims include: * Measure RA disease activity and functional/biomarker metrics during and after a 2- week course of spleen-directed daily ultrasound treatments (within-arm and between-arm assessments); and * Monitor adverse events during and after daily ultrasound treatments.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Study device treatment	The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
DEVICE	Sham device treatment	A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.

Timeline

• Start date: 2018-10-03
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2018-10-01
• Last updated: 2022-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study