A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
NCT ID: NCT04192591
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
166 participants
INTERVENTIONAL
2020-01-30
2041-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Superion™ IDS device
Superion™ Indirect Decompression System (IDS)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
45 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Bloom Lyons
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Coastal Research Institute, LLC
Carlsbad, California, United States
MarinHealth Spine Institute
Larkspur, California, United States
Vitamed Research
Rancho Mirage, California, United States
IPM Medical Group Inc.
Walnut Creek, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
The Orthopaedic Institute
Gainesville, Florida, United States
Alliance Spine and Pain Centers
Atlanta, Georgia, United States
Centurion Spine and Pain
Waycross, Georgia, United States
North Idaho Day Surgery
Post Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Pain Specialists
Ypsilanti, Michigan, United States
Weill Cornell Medical University
New York, New York, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
SC Pain and Spine Specialists
Murrells Inlet, South Carolina, United States
Precision Spine Care
Tyler, Texas, United States
Swedish Health Services
Seattle, Washington, United States
Northwest Pain Care
Spokane, Washington, United States
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia, United States
Countries
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Other Identifiers
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A4082
Identifier Type: -
Identifier Source: org_study_id