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

NCT04192591 · tracked via the Priya Life Science USA tracker

Sponsor

Boston Scientific Corporation

Phase

Not applicable

Started

2020-01-30

Last updated

2026-10-09

Condition(s) studied

Lumbar Spinal Stenosis

Investigational drug(s) / intervention(s)

Superion™ IDS device

Superion™ IDS 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.

Study summary

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

Eligibility

Sex

ALL

Min age

45 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Rate of success at the 24-month follow-up visit — 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: 1. 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 2. No reoperations, removals, revisions, or supplemental fixation at the index level(s) 3. 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

Trial sites (23)

Facility	City	Region
Coastal Research Institute, LLC	Carlsbad	California
MarinHealth Spine Institute	Larkspur	California
Vitamed Research	Rancho Mirage	California
IPM Medical Group Inc.	Walnut Creek	California
Holy Cross Hospital	Fort Lauderdale	Florida
The Orthopaedic Institute	Gainesville	Florida
Alliance Spine and Pain Centers	Atlanta	Georgia
Centurion Spine and Pain	Waycross	Georgia
North Idaho Day Surgery	Post Falls	Idaho
Rush University Medical Center	Chicago	Illinois
Ascension Alexian Brothers	Elk Grove Village	Illinois
University of Kansas Hospital	Kansas City	Kansas
Neuroscience Research Center, LLC	Overland Park	Kansas
Brigham and Women's Hospital	Boston	Massachusetts
Michigan Pain Specialists	Ypsilanti	Michigan
Weill Cornell Medical University	New York	New York
Pacific Sports and Spine, LLC	Eugene	Oregon
Center for Interventional Pain and Spine	Lancaster	Pennsylvania
SC Pain and Spine Specialists	Murrells Inlet	South Carolina
Precision Spine Care	Tyler	Texas
Swedish Health Services	Seattle	Washington
Northwest Pain Care	Spokane	Washington
The Spine and Nerve Center of Saint Francis Hospital	Charleston	West Virginia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04192591 on ClinicalTrials.gov ↗ ← All trials in the USA