NCT00749073

The Vertos MILD™ Preliminary Patient Evaluation Study

A Single-center, Prospective, Clinical Study to Assess the Clinical Application and Outcomes of Minimally Invasive Lumbar Decompression With the MILD™ Devices in Patients With Symptomatic Central Foraminal Lumbar Spinal Stenosis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vertos Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.

Detailed description

The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. Lumbar decompression is performed through the removal of tissue and bone, where indicated. All procedures are conducted in accordance with the product labeling and indications for use. A minimum of ten up to a maximum of twenty-five adult patients will be enrolled and followed for a period of up to 6 months. Patients with symptomatic lumbar spinal stenosis who meet the study enrollment criteria will be offered the MILD™ procedure as an alternative to surgery or continued standard non-surgical medical management.

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DEVICE	Minimally Invasive Lumbar Decompression (MILD™)	The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-09-09
• Last updated: 2013-04-10
• Results posted: 2013-04-04

Locations

1 site across 1 country: Canada