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High Intensity Focused Ultrasound Device

Neurolyser XR for Lumbar Facet Syndrome

N/A

Waitlist Available

Research Sponsored by FUSMobile Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: base line, procedure day, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure

Awards & highlights

Study Summary

This trial is testing a new device to see if it is safe and effective for treating chronic low back pain.

Eligible Conditions

Lumbar Facet Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

NRS

Therapeutic procedure

Secondary outcome measures

Lesion Size

Oswestry Disability Index (ODI)

Patient Global Impression of Change (PGIC)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

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Who is running the clinical trial?

FUSMobile Inc.Lead Sponsor

6 Previous Clinical Trials

140 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the intended outcomes of this experiment?

"The objective of this trial, to be evaluated after a 6-month period, is the numeric rating scale. Secondary outcomes include Patient Global Impression of Change (ranges 1 - 7), Oswestry Disability Index (assessed via Low Back pain Questionnaire with a range 0% - 100%), as well as Procedure and Device Safety based on adverse events incidence & severity."

Answered by AI

Are there plentiful medical centers undertaking this research in North America?

"This trial is available in 5 distinct locations, including Montréal and Toronto. Furthermore, Oakville serves as a third site for enrolment. To reduce travelling costs, participants are encouraged to choose the closest clinic possible."

Answered by AI

Does this experiment accept elderly participants aged 85 or below?

"This particular clinical trial has set the age range of qualification to those 55-85. Comparatively, there are 386 studies open for people under 18 and 1250 trials available for elderly patients over 65 years old."

Answered by AI

Is this medical trial currently recruiting participants?

"The clinical trial registry on clinicialtrials.gov indicates that this particular medical study is not presently scouting for patients, despite having been initially posted on September 24th of 2019 and recently edited on November 28th 2022. Fortunately, there are 1727 other trials actively recruiting right now."

Answered by AI