Safety and Initial Feasibility of Using the Neurolyser fo... | NCT03321344

Studies
Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain

NCT03321344

Sponsor

FUSMobile Inc.

Status

Completed

Last Update Posted

Jan 25, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Facet Related Low Back Pain

Interventions

Focused Ultrasound Thermal ablation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2017Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Feb 19, 2020Actual

First Submitted Date

Oct 18, 2017

First Submission Date that Met QC Criteria

Oct 22, 2017

First Posted Date

Oct 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Name	Class
Focused Ultrasound Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s

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 McGill University.

Study population: Ten adult patients diagnosed with facet related low back pain.

Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain.

Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Arm	Experimental	Focused Ultrasound Thermal ablation of the Medial Nerve Branch	Device: Focused Ultrasound Thermal ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Focused Ultrasound Thermal ablation	Device	Focused Ultrasound Thermal ablation of the Medial Nerve Branch	Test Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NRS	Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain	Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure
RMD	Reduction in Rolland Morris Disability Questionnaire score	Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure
Saftey	Safety will be measured by the incidence and severity of treatment related adverse events	Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male and females, legally able and willing to participate in the study and come for follow-up visits
Able and willing to fill the study forms and to communicate with investigator
Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration
Patients presenting with a) a positive (>70% pain relief) to a previous L1 to L5 lumbar medial branch block and / or b) with a positive (>70% pain relief) to a previous lumbar facet thermal RF denervation within the last 6 months)
Average pain score of 4 or higher in the last month, (on a scale of 0 to 10)

Exclusion Criteria:

Pregnant or breastfeeding patient
Patients younger than 18 or older than 80 years
Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain).
History of spine surgery
Presence of metal hardware at the lumbosacral spine
Lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI)
Patients unable to understand and complete the research questionnaires in English or French
Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
Patient with extensive scarring in the skin and tissue overlying the treatment area.
Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Alan Edwards Pain Management Unit - Montreal General Hospital		Montreal	Quebec	H3G 1A4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34534337	Derived	Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.