Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
ConditionSacroiliitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFUSMobile Inc.
About 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.
Eligibility criteria
Qualifiers
Men and women aged 18 and older
BPI < 40
Patients who are able and willing to give consent and able to attend all study visits.
Patients who are able to communicate with the treating physician.
Disqualifiers
Patients on dialysis
Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or severe foraminal or central canal stenosis).
Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher.
Spondylolisthesis at L5/S1, or scoliosis
Trial design
Treatments tested in this trial
- High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
FUSMobile Inc.
Lead sponsor
Focused Ultrasound Foundation
Collaborator
Source ClinicalTrials.gov