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

NCT06053255 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Sacroiliitis

Interventions

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.

Sponsors & Collaborators

  • Focused Ultrasound Foundation

    collaborator OTHER

  • FUSMobile Inc.

    lead INDUSTRY

Principal Investigators

  • Lynn Kohan, MD · University of Virginia Pain Medicine Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2026-09-15
Completion
2026-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053255 on ClinicalTrials.gov