CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Percutaneous Lumbar Decompression +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01129921
NCT01129921N/ACompleted
CompareCT.gov

Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis

Napa Pain Institute·interventional·Posted May 25, 2010·Updated Jul 16, 2013

In Brief

A clinical study evaluating Percutaneous Lumbar Decompression and Sham lumbar decompression for Lumbar Spine Stenosis Central Canal. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spine Stenosis Central Canal
CountriesUnited States
CollaboratorsVertos Medical, Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.1 years ago

Interventions

Percutaneous Lumbar Decompressiondevice

Fluoroscopic percutaneous lumbar decompression of the central spinal canal

Sham lumbar decompressiondevice

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