MILD Procedure for Lumbar Spinal Stenosis
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the MILD procedure with conventional medical management or conventional medical management alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed for up to 5 years to assess long-term outcomes
Treatment Details
Interventions
- Conventional Medical Management (CMM)
- MILD Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertos Medical, Inc.
Lead Sponsor