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MILD for Lumbar Spinal Stenosis

N/A
Waitlist Available
Led By Ramsin Benyamin, MD
Research Sponsored by Vertos Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

Eligible Conditions
  • Lumbar Spinal Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Secondary outcome measures
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months

Trial Design

2Treatment groups
Active Control
Group I: MILDActive Control1 Intervention
The MILD procedure is an image-guided minimally-invasive lumbar decompression
Group II: Epidural Steroid Injection (ESI)Active Control1 Intervention
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.

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Who is running the clinical trial?

Vertos Medical, Inc.Lead Sponsor
9 Previous Clinical Trials
8,560 Total Patients Enrolled
Ramsin Benyamin, MDPrincipal InvestigatorAAPM; ASIPP; ISIS; ASA
1 Previous Clinical Trials
304 Total Patients Enrolled
Peter Staats, MDPrincipal InvestigatorAAPM; ASIPP; ASA
1 Previous Clinical Trials
231 Total Patients Enrolled
~27 spots leftby Aug 2025
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