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The Vertos MILD™ Preliminary Patient Evaluation Study

NCT00749073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-04-10

Study results available
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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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

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.

Sponsors & Collaborators

  • Vertos Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Daryl R Fourney, MD, FRCSC, FACS · University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Canada

Study Locations

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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 NCT00749073 on ClinicalTrials.gov