155 Participants Needed

MILD Procedure for Lumbar Spinal Stenosis

Recruiting at 24 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vertos Medical, Inc.
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.

Eligibility Criteria

This trial is for people with lumbar spinal stenosis causing leg pain when walking. Participants should have certain spine conditions like bone spurs or minor slipped discs but not severe ones, stable opioid use, and no recent back procedures. They must be able to attend follow-ups and haven't had the MILD procedure before.

Inclusion Criteria

I have spinal issues like osteophytes or disk protrusion but my doctor says they're not too advanced.
I can attend all required follow-up appointments.
I have had leg pain from nerve issues for at least 3 months.
See 3 more

Exclusion Criteria

I have had spinal fractures and still experience pain from them.
My doctor says fat buildup in my spine is causing narrowing.
On (or pending) Workman's Compensation or known to be considering litigation associated with back pain
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MILD procedure with conventional medical management or conventional medical management alone

12 months
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Annual visits

Long-term follow-up

Participants are followed for up to 5 years to assess long-term outcomes

5 years
Annual visits

Treatment Details

Interventions

  • Conventional Medical Management (CMM)
  • MILD Procedure
Trial Overview The study compares two treatments: the MILD procedure plus usual care versus just usual care for spinal stenosis. It's a randomized controlled trial where some patients can switch to MILD after one year if they were initially in the control group.
Participant Groups
2Treatment groups
Active Control
Group I: MILD with CMMActive Control2 Interventions
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
Group II: CMM aloneActive Control1 Intervention
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vertos Medical, Inc.

Lead Sponsor

Trials
10
Recruited
8,900+
Unbiased ResultsWe believe in providing patients with all the options.
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