An interventional study of NeurolyserXR in Sacroiliitis, sponsored by FUSMobile Inc.. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by FUSMobile Inc. · Not applicable, Interventional, and Treatment
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.
Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's planned enrollment of 10 is below the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →FUSMobile Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Treatment arm using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint
Device: NeurolyserXR
Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint
Effectiveness per pain score using numerical rating scale of 0 to 10
Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner
Time frame: Baseline throughout the follow-up period of six months
Safety per adverse events
Measured by the incidence and severity of treatment related adverse events
Time frame: Baseline throughout the follow-up period of six months
Assess self-rated physical disability caused by low back pain
Roland-Morris Disability Questionnaire providing a scale of 0 to 24 when 0 is best and 24 is worst
Time frame: Baseline throughout the follow-up period of six months
Opioid intake dosage using morphine equivalency conversion
Using by recording patient opioid intake using opioid equivalency chart
Time frame: Baseline throughout the follow-up period of six months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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FUSMobile Inc.