Neurolyser XR for Low Back Pain
AM
Overseen ByAlexi Moruza
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: FUSMobile Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with Sacroiliitis.
Research Team
LK
Lynn Kohan, MD
Principal Investigator
University of Virginia Pain Medicine Clinic
Eligibility Criteria
This trial is for adults with chronic low back pain specifically due to Sacroiliitis, who've had some relief from SI joint injections or lateral branch blocks. Participants must have ruled out other causes of back pain and be able to communicate and comply with study requirements. They should also have a significant level of pain despite previous treatments.Inclusion Criteria
I can consent to the study and attend all visits.
You must be able to verbally interact with the doctor.
My back pain is mainly below the waist.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Multiple visits (in-person)
Treatment Details
Interventions
- Neurolyser XR
Trial Overview The Neurolyser XR device is being tested in this trial. It uses high-intensity focused ultrasound to target nerves associated with Sacroiliitis-related low back pain, aiming to provide relief by ablating the lateral sacral branch nerve.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: HIFU for SacroiliitisExperimental Treatment1 Intervention
High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
FUSMobile Inc.
Lead Sponsor
Trials
7
Recruited
170+
Focused Ultrasound Foundation
Collaborator
Trials
18
Recruited
460+
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