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NCT06355791 · ClinicalTrials.gov registry record · NA
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
A NA study of Lumbar Spinal Stenosis and Spondylolisthesis, sponsored by Spinal Simplicity.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 6
- Study locations
NCT06355791: Recruiting NA study of Lumbar Spinal Stenosis and Spondylolisthesis, sponsored by Spinal Simplicity.
NCT06355791 is a NA study of Lumbar Spinal Stenosis and Spondylolisthesis that is actively recruiting participants, run by Spinal Simplicity. The registered enrollment target is 150 participants, below the 661-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (77% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06355791, a NA study of Lumbar Spinal Stenosis and Spondylolisthesis, is actively recruiting participants, sponsored by Spinal Simplicity.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
Primary Outcome
Overall pain, as well as back pain when standing/walking and leg pain when standing will be assessed using a numeric rating scale (NRS). The NRS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Conditions Studied
Interventions
- DEVICE Minuteman G5 Device
Study Locations (6)
Georgia
- Vista Clinical Research - Newnan
Indiana
- Comprehensive Pain & Spine Specialists - Indianapolis
Kansas
- University of Kansas Medical Center - Kansas City
Minnesota
- Nura Precision Pain Management - Edina
Oregon
- Pacific Sports & Spine - Eugene
West Virginia
- Spine & Nerve Center of the Virginias - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2030-12 |
| Phase | NA |
What NCT06355791 shows while recruiting
NCT06355791 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 661-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Minuteman G5 Device is the first listed.
NCT06355791 lists 6 locations in 6 states (Georgia, Indiana, Kansas).
Frequently Asked Questions
What is clinical trial NCT06355791 about?
NCT06355791 is a clinical study titled "Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device". This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine result...
What is the current status of trial NCT06355791?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-05-29. Estimated completion is 2030-12.
What conditions does trial NCT06355791 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Conditions of the Lumbar Spine.
What interventions are being tested in trial NCT06355791?
The interventions under investigation include: Minuteman G5 Device (DEVICE).
Who is sponsoring clinical trial NCT06355791?
This trial is sponsored by Spinal Simplicity, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06355791 being conducted?
This trial has 6 study locations across Georgia, Indiana, Kansas, Minnesota, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lumbar Spinal Stenosis
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Where NCT06355791's enrollment target sits among peer trials
150 7th of 18 higher than 11 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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