The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

September 19, 2013 updated by: Baxano Surgical, Inc.
The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Castro Valley, California, United States, 94546
        • Eden Medical Center
      • Los Angeles, California, United States, 90036
        • Olympia Medical Center
      • Watsonville, California, United States, 95076
        • Watsonville Community Hospital
    • Georgia
      • Cumming, Georgia, United States, 30041
        • Resurgens Orthopaedics
    • Illinois
      • Bartlett, Illinois, United States, 60103
        • Suburban Orthopedics
    • Missouri
      • Jefferson City, Missouri, United States, 65101
        • Spine Midwest, Inc.
      • Joplin, Missouri, United States, 64804
        • McCune-Brooks Regional Hospital
    • New York
      • Lockport, New York, United States, 14094
        • Buffalo Spine Surgery
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Triangle Orthopaedic Associates
      • Greensboro, North Carolina, United States, 27401
        • Moses Cone Hospital
      • Lenoir, North Carolina, United States, 28645
        • Caldwell Memorial Hospital
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Rothman Institute
      • Easton, Pennsylvania, United States, 18017
        • Easton Hospital
    • South Carolina
      • Greenwood, South Carolina, United States, 29646
        • Carolina Neurosurgery & Spine Center
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Neurospine Solutions, PC
    • Texas
      • North Richland Hills, Texas, United States, 76182
        • Spine Works Institute
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Tuckahoe Orthopaedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at least 18 years of age presenting with failed conservative treatment for one or two level lumbar spinal stenosis

Description

Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

  1. Age ≥18 years
  2. Leg/buttock pain with or without back pain
  3. Failed nonoperative medical management
  4. A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
  5. Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
  6. Able and willing to give voluntary, written informed consent to participate in this clinical study

Exclusion Criteria

Candidates will be excluded from the evaluation if ANY of the following apply:

  1. Back pain only
  2. A diagnosis of central stenosis only
  3. More than two levels requiring decompression
  4. Fixed motor deficit
  5. Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs
  6. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
  7. Primary disc pathology and/or patients who will undergo a discectomy
  8. Prior surgery of the lumbar spine at the level(s) of planned treatment
  9. Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4)
  10. Spondylolysis (pars fracture) at any level in the lumbar spine
  11. Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25°
  12. Symptomatic vascular claudication in the lower extremities
  13. Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction)
  14. Evidence of active (systemic or local) infection at time of surgery
  15. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
  16. Tumor in the spine or a malignant tumor except for basal cell carcinoma
  17. Prisoner or transient
  18. Recent history of known narcotic abuse
  19. Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires
  20. Involved in pending litigation of the spine or worker's compensation related to the back
  21. Inability to communicate clearly in the English language
  22. Morbid obesity (BMI > 40)
  23. Plans to relocate within the next 2 years
  24. Pregnant or planning to become pregnant

  25. Irreversible coagulopathy or bleeding disorder

    a. Subjects on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.

  26. Subject unwilling to undergo blood transfusion, if necessary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
iO-Flex
Device: Baxano iO-Flex® System
Decompressive lumbar surgery using Baxano iO-Flex® System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points
Time Frame: 6 months
6 months
Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30%
Time Frame: 6 months
6 months
Re-operation at the treatment level(s) at one year post-procedure
Time Frame: One year
One year
Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects
Time Frame: Hospital discharge
Hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in Visual Analog Scale scores compared to baseline
Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
6 weeks, 3 months, 6 months, 12 months, 24 months
Changes in Zurich Claudication Questionnaire scores compared to baseline
Time Frame: 6 weeks, 3, 6, 12, and 24 months
6 weeks, 3, 6, 12, and 24 months
Changes in Oswestry Disability Index scores compared to baseline
Time Frame: 6 weeks, 3, 6, 12, and 24 months
6 weeks, 3, 6, 12, and 24 months
Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months
Time Frame: 6, 12, and 24 months
6, 12, and 24 months
Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems
Time Frame: Through 2 years
Through 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxano Surgical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-1318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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