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Clinical trialNCT01338766UnknownInterventional

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

SponsorBaxano Surgical, Inc.Enrollment100Lumbar Spinal StenosisRadiculopathySpondylolisthesis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Eden Medical Center

    Castro Valley, California, United States

  • Olympia Medical Center

    Los Angeles, California, United States

  • Orange County Neurological Associates

    Mission Viejo, California, United States

  • University California Irvine

    Orange, California, United States

  • Southern California Orthopedic Institute

    Van Nuys, California, United States

  • Georgetown University

    Washington D.C., District of Columbia, United States

  • Medical Center of Trinity

    Odessa, Florida, United States

  • Florida Orthopaedic Institute

    Temple Terrace, Florida, United States

  • Resurgens Orthopaedics

    Cumming, Georgia, United States

  • Suburban Orthopedics

    Bartlett, Illinois, United States

  • Indiana Spine Group

    Carmel, Indiana, United States

  • Scott and White Memorial Hospital

    Temple, Texas, United States

  • Tuckahoe Orthopedics

    Richmond, Virginia, United States

  • Vcu Medical Center

    Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2011
Primary completion
31 Dec 2014
Completion
—
Last update posted
23 Apr 2014
Registered enrollment
100
Registry id
NCT01338766

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.