MedTrace Logo

Vertos Mild - Post Market Patient Outcomes

NCT01076244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2013-04-02

Study results available
· View outcomes & findings →

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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Minimally Invasive Lumbar Decompression

This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.

Sponsors & Collaborators

  • Vertos Medical, Inc.

    collaborator INDUSTRY

  • The Center for Pain Relief, Inc.

    lead OTHER

Principal Investigators

  • Timothy R Deer, MD · Center for Pain Relief, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076244 on ClinicalTrials.gov