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Procedure

MILD Procedure for Lumbar Spinal Stenosis

N/A

Waitlist Available

Research Sponsored by Vertos Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Available to complete all follow-up visits

Patients experiencing neurogenic claudication symptoms for at least 3 months duration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12month

Awards & highlights

Study Summary

This trial is testing whether a new treatment for lumbar spinal stenosis (LSS) is better than the current standard of care. The new treatment is called the MILD procedure, and it will be compared to conventional medical management (CMM) alone. The study will last for 12 months, and subjects in the control group will be able to crossover and receive the MILD procedure after the study is completed.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks of procedures like MILD may include infection, bleeding, nerve damage, or no improvement in symptoms. Usual medical management could also have side effects depending on the treatment used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can attend all required follow-up appointments.

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I have had leg pain from nerve issues for at least 3 months.

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My opioid medication dose has been stable for the last 30 days.

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I have leg pain when walking due to spinal issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change in Oswestry Disability Index (ODI)

Secondary outcome measures

Mean Change in Numeric Pain Rating Scale (NPRS)

Mean Change in Zurich Claudication Questionaire (ZCQ)

Walking Tolerance Test

Trial Design

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Vertos Medical, Inc.Lead Sponsor

9 Previous Clinical Trials

8,707 Total Patients Enrolled

Media Library

MILD Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03610737 — N/A

Lumbar Spinal Stenosis Research Study Groups: MILD with CMM, CMM alone

Lumbar Spinal Stenosis Clinical Trial 2023: MILD Procedure Highlights & Side Effects. Trial Name: NCT03610737 — N/A

MILD Procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03610737 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which geographic areas are the research activities for this project occurring?

"This trial is predominantely operating from MAO Leawood Surgery Center, LLC in Kansas, Santa Barbara Outpatient Surgery Center LLC in California and Coastal Surgery Center in Florida. Additionally, there are 25 other sites participating nationwide."

Answered by AI

Does this research project accept participants aged 80 or above?

"The age range for inclusion into this medical trial is between 50 and 80 years old."

Answered by AI

Are applications currently being accepted for this research endeavor?

"Unfortunately, clinicaltrials.gov displays that no more participants are being recruited to this study at the moment; although first posted August 2nd 2018 and last edited October 12th 2021, it has been closed for enrollment. However, those interested can find solace in knowing there are 258 other studies currently searching for volunteers."

Answered by AI

To what population can this experiment be administered?

"To be considered, individuals must have a lumbar region malady and fall within the age bracket of 50 to 80. This trial is looking to recruit roughly 150 patients."

Answered by AI