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

Must not be taking: Epidural injections

Disqualifiers: Low ODI/NPRS scores, Prior surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

155 Participants Needed

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.

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

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

Group I: MILD with CMM Active Control 2 Interventions

The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment

Group II: CMM alone Active Control 1 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.

Who Is Running the Clinical Trial?

Vertos Medical, Inc.

Lead Sponsor

Trials

10

Recruited

8,900+