Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519541
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2020-08-17
Brief Title:
RAMBAM 021 Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain
Sponsor:
FUSMobile Inc
Organization:
FUSMobile Inc
Study Overview
Official Title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
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 12 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 12 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:
None
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?:
None