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Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

NCT01338766 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.

Conditions

  • Radiculopathy
  • Spondylolisthesis
  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Decompression using the iO-Flex® system

Decompression using the iO-Flex® system

Sponsors & Collaborators

  • Baxano Surgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Sylvain Palmer, M.D. · Neurological Surgery Medical Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-12-31

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 NCT01338766 on ClinicalTrials.gov