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Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

NCT01129921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-07-16

Study results available
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Summary

This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.

Conditions

  • Lumbar Spine Stenosis Central Canal

Interventions

DEVICE

Percutaneous Lumbar Decompression

Fluoroscopic percutaneous lumbar decompression of the central spinal canal

DEVICE

Sham lumbar decompression

Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.

Sponsors & Collaborators

  • Vertos Medical, Inc.

    collaborator INDUSTRY

  • Napa Pain Institute

    lead OTHER

Principal Investigators

  • Eric Grigsby, MD · Napa Pain Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

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 NCT01129921 on ClinicalTrials.gov