MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

(MiDAS III Trial)

Recruiting in Palo Alto (17 mi)

+26 other locations

Overseen by Nagy Mekhail, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vertos Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

Research Team

Nagy Mekhail, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5.

Prior failure of conservative therapy.

Oswestry Disability Index (ODI) score of ≥ 31%.

Treatment Details

Interventions

• Epidural Steroid Injection (Corticosteroid)
• Mild® Procedure (Decompression)

Participant Groups

Group I: Percutaneous Lumbar Decompression Active Control 1 Intervention

Patients receiving percutaneous decompression using the mild® Device Kit.

Group II: Lumbar Epidural Steroid Injection Active Control 1 Intervention

Injection of epidural steroids into the lumbar spine

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The GW Pain Center Washington, United States

Neurospine Institute Eugene, OR

Space City Pain Specialists, LLP Webster, TX

The Center for Pain Relief, Inc. Charleston, WV

More Trial Locations

Who Is Running the Clinical Trial?

Vertos Medical, Inc.

Lead Sponsor

Trials

10

Patients Recruited

8,900+