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NCT02079038 · ClinicalTrials.gov registry record · NA
The STEPS - Totalis™ Trial
A NA study of Lumbar Spinal Stenosis, sponsored by VertiFlex, Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 19
- Study locations
NCT02079038 is a NA study of Lumbar Spinal Stenosis that has completed, run by VertiFlex, Incorporated. The registered enrollment target is 180 participants, below the 659-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (73% lower). The trial reports 19 study locations across 14 states.
The verdict
NCT02079038, a NA study of Lumbar Spinal Stenosis, has completed, sponsored by VertiFlex, Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 19
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DEVICE Totalis
- PROCEDURE Comparator Surgical Procedure
Study Locations (19)
California
- Medhat Mikhael, M.D. Inc. - Fountain Valley
- Orthopedic Pain Specialists - Santa Monica
- Integrated Pain Management Medical Group, Inc. - Walnut Creek
Arizona
- Hope Research Institute - Phoenix
- Arizona Pain Specialists - Scottsdale
Florida
- Holy Cross Hospital - Fort Lauderdale
- Florida Pain Institute - Merritt Island
Pennsylvania
- Penn State Hershey Medical Center - Hershey
- Performance Spine and Sports Physicians, PC - Pottstown
Alabama
- Alabama Clinical Therapeutics - Birmingham
District of Columbia
- GWU - Medical Faculty Associates, Inc. - Washington D.C.
Georgia
- Pain Care, LLC - Stockbridge
Indiana
- American Health Network - Muncie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02079038
The ClinicalTrials.gov registry entry for NCT02079038 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (73% lower). The listed sponsor is VertiFlex, Incorporated, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Totalis is the first listed.
NCT02079038 reports 19 study locations spanning 14 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT02079038 about?
NCT02079038 is a clinical study titled "The STEPS - Totalis™ Trial". 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...
What is the current status of trial NCT02079038?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2014-05. Estimated completion is 2017-01.
What conditions does trial NCT02079038 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis.
What interventions are being tested in trial NCT02079038?
The interventions under investigation include: Totalis (DEVICE), Comparator Surgical Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT02079038?
This trial is sponsored by VertiFlex, Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02079038 being conducted?
This trial has 19 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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