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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: Completed NA study of Lumbar Spinal Stenosis, sponsored by VertiFlex, Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or
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 |
What the finished NCT02079038 record still lists
NCT02079038 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 659-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (73% lower).
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 lists 19 locations in 14 states (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.
Learn More About Clinical Trials
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Where NCT02079038's enrollment target sits among peer trials
180 5th of 18 higher than 14 of 18 other Lumbar Spinal Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lumbar Spinal Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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