Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 10:22 PM
Study NCT ID:
NCT04129034
Status:
UNKNOWN
Last Update Posted:
2022-12-01
First Post:
2019-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Sponsor:
FUSMobile Inc.
Organization:
Study Overview
Official Title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_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:
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
Detailed Description:
Study design: Prospective, single arm
Timeline: six month enrollment period and 6 months follow-up period.
Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \& Spine, Kinetix Integrated Orthopaedic \& Regenerative Medicine
Study population: Thirty adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.
Safety is measured by the incidence and severity of treatment related adverse events.
Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.
Timeline: six month enrollment period and 6 months follow-up period.
Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \& Spine, Kinetix Integrated Orthopaedic \& Regenerative Medicine
Study population: Thirty adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.
Safety is measured by the incidence and severity of treatment related adverse events.
Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 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?: