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Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
NCT06355791 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06355791
The ClinicalTrials.gov registry entry for NCT06355791 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spinal Simplicity, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06355791 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Georgia, Indiana, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06355791?
The interventions under investigation include: Minuteman G5 Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06355791?
This trial is sponsored by Spinal Simplicity, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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