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

August 19, 2015 updated by: Vertos Medical, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
      • Scottsdale, Arizona, United States, 85257
        • Center for Pain and Supportive Care
    • California
      • Aptos, California, United States, 95003
        • Pain Clinic of Monterey Bay
      • Chula Vista, California, United States, 91914
        • Pain Control Associates of San Diego
      • Solana Beach, California, United States, 92075
        • Navarro Pain Control Group, Inc.
      • Walnut Creek, California, United States, 94598
        • IPM Medical Group, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The GW Pain Center
    • Florida
      • Aventura, Florida, United States, 33108
        • Interventional Pain Physicians of South Florida
      • Bradenton, Florida, United States, 34209
        • Coastal Orthopedics and Sports Medicine
      • Fort Lauderdale, Florida, United States, 33334
        • Holy Cross Interventional Spine & Pain Medicine Center
      • Merritt Island, Florida, United States, 32953
        • Space Coast Pain Institute
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Millennium Pain Center
    • Kentucky
      • Frankfort, Kentucky, United States, 40601
        • Commonwealth Pain Specialists, PLLC
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • The Spine Center Baltimore
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Michigan Pain Specialists
      • Brownstown Twp., Michigan, United States, 48183
        • Michigan Interventional Pain Center
    • Missouri
      • Crystal City, Missouri, United States, 63019
        • Occupational and Pain Management Professionals
    • Nevada
      • Las Vegas, Nevada, United States, 89149
        • Lab2Marche' LLC
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Virtua Pain and Spine Specialists
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Eugene, Oregon, United States, 97401
        • NeuroSpine Institute
    • Texas
      • Tyler, Texas, United States, 75701
        • Axis Spine Care
      • Webster, Texas, United States, 77598
        • Space City Pain Specialists, LLP
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • The Center for Pain Relief, Inc.
      • Huntington, West Virginia, United States, 25702
        • The Center for Pain relief Tri-State

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Percutaneous Lumbar Decompression
Patients receiving percutaneous decompression using the mild® Device Kit.
Procedure: Percutaneous 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.
Other Names:
  • mild procedure
  • mild lumbar decompression
Active Comparator: Lumbar Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Drug: Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Other Names:
  • ESI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertos Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nagy Mekhail, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MiDAS III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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