NCT06053255

Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: FUSMobile Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The sacroiliac joint connects the sacrum (a triangle shaped bone) with the iliac bone on both sides of the lower spine. These joints transmit all the forces from the upper body to the pelvis and their respective legs. Repeated trauma and aging affect this joint resulting in inflammation and arthritic changes. These changes result in misalignment of the joint or limitation to normal motion which can create pain typically very low in the back or in the buttocks, High-Intensity Focused Ultrasound (HIFU) technology uses sound waves. These sound waves are concentrated into a specific spot in order to raise the local tissue temperature causing a burn, this burn is expected to intentionally damage the nerve causing pain. The HIFU device used in this study is called, the Neurolyser XR. It focuses sound wave energy directly on the nerve of the painful sacroiliac joint, causing an increase in temperature, which is expected to directly damage the nerve fibers which carry pain signals to the brain.

Conditions

• Sacroiliitis

Interventions

Type	Name	Description
DEVICE	High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR	HIFU is delivered via a non-invasive ultrasonic transducer, through a gel pad for acoustic coupling, into the patients body in a precise manner focused on the lateral sacral branch nerves.

Timeline

• Start date: 2024-09-13
• Primary completion: 2026-09-15
• Completion: 2026-12-15
• First posted: 2023-09-25
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study