Lumbar Spinal StenosisMiDAS IIINCT01315145
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
A study testing Percutaneous Lumbar Decompression and Epidural Steroid Injection in people with Lumbar Spinal Stenosis, run by Vertos Medical, Inc. at 27 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Percutaneous Lumbar Decompression and Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 27 sitesUnited States
- Study dates
- Mar 2011to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
- Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit.
- Able to walk ≥ 10 feet before being limited by pain.
- Available to complete 24-months of follow-up.
- Adults ≥ 50 years of age.
Who cannot join
- Prior surgery at intended treatment level.
- History of spinal fractures with current related pain symptoms.
- Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.).
- Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results.
- Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results.
- Significant symptomatic foraminal stenosis.
Show all 20Show fewer
- Confirmed anterior or retro-listhesis ≥ 3mm.
- Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure.
- Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain.
- Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain.
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment.
- Pregnant and/or breastfeeding.
- Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared.
- Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure.
- Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms.
- Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
- On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
- Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.).
- Intrathecal pump.
- Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Michigan Pain Specialists
Ann Arbor, Michigan, 48105
Pain Clinic of Monterey Bay
Aptos, California, 95003
Interventional Pain Physicians of South Florida
Aventura, Florida, 33108
The Spine Center Baltimore
Baltimore, Maryland, 21211
Millennium Pain Center
Bloomington, Illinois, 61701
Coastal Orthopedics and Sports Medicine
Bradenton, Florida, 34209
Michigan Interventional Pain Center
Brownstown Twp., Michigan, 48183
The Center for Pain Relief, Inc.
Charleston, West Virginia, 25301
Pain Control Associates of San Diego
Chula Vista, California, 91914
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Occupational and Pain Management Professionals
Crystal City, Missouri, 63019
Neurospine Institute
Eugene, Oregon, 97401
Holy Cross Interventional Spine & Pain Medicine Center
Fort Lauderdale, Florida, 33334
Commonwealth Pain Specialists, PLLC
Frankfort, Kentucky, 40601
The Center for Pain relief Tri-State
Huntington, West Virginia, 25702
Lab2Marche' LLC
Las Vegas, Nevada, 89149
Space Coast Pain Institute
Merritt Island, Florida, 32953
HOPE Research Institute
Phoenix, Arizona, 85050
Center for Pain and Supportive Care
Scottsdale, Arizona, 85257
Navarro Pain Control Group, Inc.
Solana Beach, California, 92075
Stony Brook University Medical Center
Stony Brook, New York, 11794
Axis Spine Care
Tyler, Texas, 75701
Virtua Pain and Spine Specialists
Voorhees Township, New Jersey, 08043
IPM Medical Group, Inc.
Walnut Creek, California, 94598
The GW Pain Center
Washington D.C., District of Columbia, 20037
Space City Pain Specialists, LLP
Webster, Texas, 77598
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
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.
Read the detailed description
The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Percutaneous Lumbar Decompression, Epidural Steroid Injection
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Lumbar DecompressionProcedure or surgery
Also called mild procedure, mild lumbar decompression
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.
Epidural Steroid InjectionDrug
Also called ESI
Injection of epidural steroids into the lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Lumbar Decompression | Active comparator | Patients receiving percutaneous decompression using the mild® Device Kit. Receives: Procedure: Percutaneous Lumbar Decompression |
| Lumbar Epidural Steroid Injection | Active comparator | Injection of epidural steroids into the lumbar spine Receives: Drug: Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertos Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nagy Mekhail, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315145
- Sponsor's protocol ID
- MiDAS III
- Acronym
- MiDAS III
- Status last verified
- Aug 2015
- First submitted
- 11 Mar 2011
- Last updated
- 31 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
- ClinicalTrials.gov ID
- NCT01315145
- Acronym / sponsor ID
- MiDAS III / MiDAS III
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Vertos Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Posted 19 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Lumbar Decompression | Active comparator | Procedure: Percutaneous Lumbar DecompressionPatients receiving percutaneous decompression using the mild® Device Kit. |
| Lumbar Epidural Steroid Injection | Active comparator | Drug: Epidural Steroid InjectionInjection of epidural steroids into the lumbar spine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
- Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit.
- Able to walk ≥ 10 feet before being limited by pain.
Key exclusion criteria (20 listed)
- Prior surgery at intended treatment level.
- History of spinal fractures with current related pain symptoms.
- Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.).
- Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results.
- Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Lumbar DecompressionAlso: mild procedure, mild lumbar decompressionThe 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. | Procedure or surgery | Percutaneous Lumbar Decompression |
| Epidural Steroid InjectionAlso: ESIInjection of epidural steroids into the lumbar spine | Drug | Lumbar Epidural Steroid Injection |
Primary outcome
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
Time frame: 16 weeks
The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagy Mekhail, MD principal investigator
The Cleveland Clinic
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Lumbar Decompression and Epidural Steroid Injection in people with Lumbar Spinal Stenosis, run by Vertos Medical, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.