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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
FUSMobile Inc.
Study ID
NCT06053255
Status
Recruiting
Apply to this trial

Conditions

  • Sacroiliitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 13, 2024
Status verified
May 2025
Primary completion
Sep 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HIFU for Sacroiliitis
    High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.

Primary Outcome Measure

The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [ Time Frame: Procedure through 6 month follow-up visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia, Department of AnesthesiologyCharlottesvilleVirginia22903
Sierra B Clark
[email protected]
434-924-3627
Lynn R Kohan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By research site
University of Virginia, Department of Anesthesiology· Charlottesville, VA

Related Studies