Trials / Completed
CompletedNCT02093520
The MiDAS ENCORE Study
MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Vertos Medical, Inc. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | MILD Procedure | The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. |
| DRUG | Epidural Steroid Injection | Injection of epidural steroids into the lumbar spine |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2016-05-01
- Completion
- 2017-10-01
- First posted
- 2014-03-21
- Last updated
- 2017-12-06
- Results posted
- 2017-07-17
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02093520. Inclusion in this directory is not an endorsement.