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Ultrasound Therapy
Splenic Ultrasound for Rheumatoid Arthritis (ULTRA Trial)
N/A
Waitlist Available
Led By Erik Peterson, M.D.
Research Sponsored by SecondWave Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study participation
Awards & highlights
ULTRA Trial Summary
This trial will assess whether or not spleen ultrasound stimulation is effective in treating rheumatoid arthritis in a pilot study.
Eligible Conditions
- Rheumatoid Arthritis
ULTRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Within-arm change in the Disease Activity Score (DAS-28-CRP) from baseline to the completion of an up-to 8-week treatment period.
Other outcome measures
Exit interview questions.
Within-arm change of serum Interferon gamma (IFN-gamma) concentration.
Within-arm change of serum Interleukin-1 beta (IL-1beta) concentration.
+8 moreULTRA Trial Design
1Treatment groups
Experimental Treatment
Group I: Ultrasound GroupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Splenic Ultrasound
2021
N/A
~80
Find a Location
Who is running the clinical trial?
SecondWave Systems Inc.Lead Sponsor
3 Previous Clinical Trials
113 Total Patients Enrolled
University of MinnesotaOTHER
1,379 Previous Clinical Trials
1,588,482 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
1,767 Patients Enrolled for Rheumatoid Arthritis
DARPA (United States Department of Defense)UNKNOWN
1 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are showing signs that your inflammatory disease is not under control.You are currently taking part in a study for an experimental drug or medical device.You have synovitis in at least 1 joint, you have no alternative diagnosis that better explains the synovitis, and you have a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains.The doctors in charge of the study have determined that you are not a suitable candidate for this study due to other medical reasons.You do not have a spleen.You have a medical device implanted in your body.You have open cuts or sores near the areas where the treatment will be applied.
Research Study Groups:
This trial has the following groups:- Group 1: Ultrasound Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05417854 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial still open and inviting participants?
"As per the most recent update on clinicaltrials.gov, this trial is still engaging participants. It was initially publicised on June 29th 2022 and has since been revised."
Answered by AI
What is the current participation rate of this experiment?
"Affirmative. On clinicaltrials.gov, it is noted that the trial first posted on June 29th 2022 and was last modified on July 1st of the same year is actively recruiting for 15 participants across 2 sites."
Answered by AI
Who else is applying?
What state do they live in?
Kansas
Wisconsin
What site did they apply to?
University of Minnesota Health Clinics and Surgery Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I would like to find a method to get my RA under control. Because I am interested in alternative control of my disease.
PatientReceived no prior treatments
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