Post Lumbar Radiofrequency Neurotomy Imaging | NCT05122611

Studies
Post Lumbar Radiofrequency Neurotomy Imaging

NCT05122611

Sponsor

FUSMobile Inc.

Status

Completed

Last Update Posted

Nov 17, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Facet Joint Pain

Interventions

no intervention, imaging study only

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

Aug 2021

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

Feb 26, 2020Actual

Primary Completion Date

Jan 7, 2021Actual

Completion Date

Jan 11, 2021Actual

First Submitted Date

Aug 20, 2021

First Submission Date that Met QC Criteria

Nov 14, 2021

First Posted Date

Nov 17, 2021Actual

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

Nov 14, 2021

Last Update Posted Date

Nov 17, 2021Actual

Description Module

Brief Summary

MRI imaging post radio frequency ablation procedure for facet arthritis

Detailed Description

This study is an imaging study. Following a radio frequency ablation procedure for facet arthritis low back pain the patient can join the imaging study.

During the study the patient undergo contrast enhanced MRI imaging of the lumbar spine Once the imaging is done the patient finishes the study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention, imaging study only	Other	Imaging study only

Measure	Description	Time Frame
MRI imaging of the lumbar spine	MRI imaging of the lumbar spine	Up to 5 days after the RFA procedure (which was done before the study)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male and females, legally able and willing to participate in the study
Able and willing to complete the research questionnaires and communicate with the investigator and research team
Patients who are scheduled to have bilateral or unilateral treatment by radiofrequency neurotomy for chronic lumbar pain.

Exclusion Criteria:

Pregnant or breastfeeding patient
Patients younger than 18
Patients unable to understand and complete the research questionnaires in English
Patient with any contraindication for MRI contrast agents - Patients with known intolerance or allergies to the MRI contrast agent (e.g., Gadovist) including advanced kidney disease
Patients with a pacemaker, implanted defibrillator or internal pacing wires.
Patient with mechanical heart valve
Patient with an aneurysm clip
Patient with eye surgery or injury involving a metallic object
Patient with ear surgery or implanted device to the ear
Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator
Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury
Patient with vascular clamp, filter, coil or stent
Pregnant or breast-feeding patient
Patient with anemia, liver disease or history of MRI contrast reaction
Patient with any known kidney disease, prior kidney surgery or on dialysis
Patient with hypertension or diabetes that requires medication
Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
Patients who are claustrophobic or known adverse psychological reactions with previous MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients volunteering to receive an MRI scan with and without contrast following radiofrequency neurotomy treatment for chronic lumbar pain

Sampling Method

Non-Probability Sample