Vertos Mild - Post Market Patient Outcomes

Lumbar Spinal Stenosis Clinical Trial

Official title: Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.

Status Completed

Clinical Trial Summary

This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.

Clinical Trial Description

Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

• NCT number: NCT01076244
• Study type: Interventional
• Source: The Center for Pain Relief, Inc.
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Completion date: January 2012