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Ultrasound Treatment of Rheumatoid Arthritis

NCT03690466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-06-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Erik Peterson, MD PHD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2022-04-28
Completion
2022-04-28
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 NCT03690466 on ClinicalTrials.gov