Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-02-25 @ 6:32 PM
Study NCT ID:
NCT05396495
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2022-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain
Sponsor:
FUSMobile Inc.
Organization:
Study Overview
Official Title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: