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NCT02555280 · ClinicalTrials.gov registry record · NA
Coflex PS3 Actual Conditions for Use Study
A NA study of Spinal Stenosis Lumbar, sponsored by Xtant Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 19
- Study locations
NCT02555280: Recruiting NA study of Spinal Stenosis Lumbar, sponsored by Xtant Medical.
NCT02555280 is a NA study of Spinal Stenosis Lumbar that is actively recruiting participants, run by Xtant Medical. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02555280, a NA study of Spinal Stenosis Lumbar, is actively recruiting participants, sponsored by Xtant Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 19
- Study locations
Study Summary
A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.
Primary Outcome
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
Conditions Studied
Interventions
- DEVICE coflex® Interlaminar Technology
- PROCEDURE Decompression
Study Locations (19)
California
- Hoag Orthopedics - Irvine
- Sutter Health - Sacramento
- Central Cost Neurological Surgery - San Luis Obispo
- Cervical Disc Center of Los Angeles - Santa Monica
Colorado
- UC Health Spine Center - Aurora
- Mercy Regional Medical Center - Durango
Indiana
- 24_Unity Surgical Center, LLC - Lafayette
- Orthopaedic Specialist of Northwest Indiana - Munster
Oregon
- Southern Oregon Orthpaedics - Medford
- Summit Spine - Portland
Arizona
- Desert Institute for Spine Care (DISC) - Phoenix
Florida
- Tallahassee Neurological Clinic - Tallahassee
Illinois
- 01L_Northshore University Health System - Evanston
Louisiana
- Spine Institute of Louisiana - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2027-11 |
| Phase | NA |
What NCT02555280 shows while recruiting
NCT02555280 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Spinal Stenosis Lumbar appearing as the primary indexed condition, and to 2 interventions - of which coflex® Interlaminar Technology is the first listed.
NCT02555280 lists 19 locations in 13 states (California, Colorado, Indiana).
Frequently Asked Questions
What is clinical trial NCT02555280 about?
NCT02555280 is a clinical study titled "Coflex PS3 Actual Conditions for Use Study". A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.
What is the current status of trial NCT02555280?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2019-09-09. Estimated completion is 2027-11.
What conditions does trial NCT02555280 study?
This clinical trial studies the following conditions: Spinal Stenosis Lumbar.
What interventions are being tested in trial NCT02555280?
The interventions under investigation include: coflex® Interlaminar Technology (DEVICE), Decompression (PROCEDURE).
Who is sponsoring clinical trial NCT02555280?
This trial is sponsored by Xtant Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02555280 being conducted?
This trial has 19 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02555280's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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