The STEPS - Totalis™ Trial
Public ClinicalTrials.gov record NCT02079038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System Versus a Sham Comparator Surgical Procedure in Patients With Lumbar Spinal Stenosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis
Study identification
- NCT ID
- NCT02079038
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2014 (Type not available)
- Primary completion
- Jan 2017 (Actual)
- Completion
- Jan 2017 (Actual)
- Last update posted
- Aug 7, 2020
2014 – 2017
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | — |
| Hope Research Institute | Phoenix | Arizona | 85018 | — |
| Arizona Pain Specialists | Scottsdale | Arizona | 85260 | — |
| Medhat Mikhael, M.D. Inc. | Fountain Valley | California | 92708 | — |
| Orthopedic Pain Specialists | Santa Monica | California | 90403 | — |
| Integrated Pain Management Medical Group, Inc. | Walnut Creek | California | 94598 | — |
| GWU - Medical Faculty Associates, Inc. | Washington D.C. | District of Columbia | 20037 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33334 | — |
| Florida Pain Institute | Merritt Island | Florida | 32953 | — |
| Pain Care, LLC | Stockbridge | Georgia | 30281 | — |
| American Health Network | Muncie | Indiana | 47304 | — |
| Pain Management Associates | Independence | Missouri | 64055 | — |
| University Pain Medicine Center | Somerset | New Jersey | 08773 | — |
| Oklahoma Pain Physicians | Oklahoma City | Oklahoma | 73120 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Performance Spine and Sports Physicians, PC | Pottstown | Pennsylvania | 19464 | — |
| SC Pain & Spine Specialists | Murrells Inlet | South Carolina | 29576 | — |
| Spine Team Texas | Southlake | Texas | 76092 | — |
| Virginia iSpine Physicians PC | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02079038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02079038 live on ClinicalTrials.gov.