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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 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.

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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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2024-05-29
Est. Completion 2030-12
Phase NA

Sponsor

Spinal Simplicity

2 total trials

What the Registry Record Tells You About NCT06355791

The ClinicalTrials.gov registry entry for NCT06355791 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 661-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (77% lower). The listed sponsor is Spinal Simplicity, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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