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NCT03610737 · ClinicalTrials.gov registry record · NA
The MOTION Study - Treatment of LSS With the MILD Procedure
A NA study of Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, sponsored by Vertos Medical.
- Active
- Registry status
- NA
- Development phase
- 155
- Enrollment target
- 18
- Study locations
NCT03610737: Active NA study of Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, sponsored by Vertos Medical.
NCT03610737 is a NA study of Spinal Stenosis, Lumbar Region, With Neurogenic Claudication that is active but no longer recruiting, run by Vertos Medical. The registered enrollment target is 155 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03610737, a NA study of Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, is active but no longer recruiting, sponsored by Vertos Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Primary Outcome
Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).
Conditions Studied
Interventions
- DEVICE MILD Procedure
- OTHER Conventional Medical Management (CMM)
Study Locations (18)
Florida
- Spine & Pain Institute of Florida - Lakeland
- SIMED - Ocala
Kansas
- Kansas Pain Management - Overland Park
- Interventional Pain Management Specialists - Overland Park
Michigan
- MI Interventional Pain Center - Brownstown
- Michigan Pain Specialists - Ypsilanti
Ohio
- Cleveland Clinic - Cleveland
- UH St. John Pain Management Center - Westlake
California
- Newport Heache & Pain - Newport Beach
Colorado
- Centura Spine Center - Colorado Springs
Indiana
- The Pain Management and Rehabilitation Center - Seymour
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2025-04-30 |
| Phase | NA |
What the registry record for NCT03610737 still lists
NCT03610737 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication appearing as the primary indexed condition, and to 2 interventions - of which MILD Procedure is the first listed.
NCT03610737 lists 18 locations in 14 states (Florida, Kansas, Michigan).
Frequently Asked Questions
What is clinical trial NCT03610737 about?
NCT03610737 is a clinical study titled "The MOTION Study - Treatment of LSS With the MILD Procedure". 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 co...
What is the current status of trial NCT03610737?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 155 participants. The study started on 2018-08-02. Estimated completion is 2025-04-30.
What conditions does trial NCT03610737 study?
This clinical trial studies the following conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication.
What interventions are being tested in trial NCT03610737?
The interventions under investigation include: MILD Procedure (DEVICE), Conventional Medical Management (CMM) (OTHER).
Who is sponsoring clinical trial NCT03610737?
This trial is sponsored by Vertos Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03610737 being conducted?
This trial has 18 study locations across California, Colorado, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03610737's enrollment target sits among peer trials
155 656th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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