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Active, Not Recruiting

NCT Number: NCT04192591

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coastal Research Institute, LLC, Carlsbad, California, United States

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About this study

To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 45 years of age or older when written informed consent is obtained
  • Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
  • Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).
  • Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
  • Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
  • Able to independently read and complete all questionnaires and assessments provided in English

Key Exclusion Criteria:

  • Axial back pain only.
  • Fixed motor deficit in lower extremity(ies) due to LSS.
  • Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor)
  • Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Treatment and study plan

Superion™ IDS device

Device

The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement.

Primary outcomes

  1. Rate of success at the 24-month follow-up visit

    Time frame: 24-Months

    Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit:

    • Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ
    • ≥ 0.5-point improvement in physical function
    • ≥ 0.5-point improvement in symptom severity
    • ≤ 2.5 point on patient satisfaction domain
    • No reoperations, removals, revisions, or supplemental fixation at the index level(s)
    • No major implant or procedure-related complications
    • no dislodgement, migration, or device deformation
    • no new or persistent worsened neurological deficit at the index level†
    • no unhealed spinous process fractures † Defined as a serious adverse event wherein there is any new/worsening of motor or sensory function at 12 months, compared to baseline, which persists to 24 months

Secondary outcomes

  1. Patient Satisfaction: VertiFlex® Patient Satisfaction Survey

    Time frame: 24-, 36-, 48- and 60-Months

    Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2038
Study completion
2041
First posted
Dec 10, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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