A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
1 other identifier
interventional
166
1 country
23
Brief Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
January 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2041
March 4, 2026
March 1, 2026
18 years
December 6, 2019
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of success at the 24-month follow-up visit
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
24-Months
Secondary Outcomes (1)
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey
24-, 36-, 48- and 60-Months
Study Arms (1)
Superion™ IDS device
EXPERIMENTALSuperion™ Indirect Decompression System (IDS)
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Coastal Research Institute, LLC
Carlsbad, California, 92009, United States
MarinHealth Spine Institute
Larkspur, California, 94939, United States
Vitamed Research
Rancho Mirage, California, 92270, United States
IPM Medical Group Inc.
Walnut Creek, California, 94598, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
The Orthopaedic Institute
Gainesville, Florida, 32607, United States
Alliance Spine and Pain Centers
Atlanta, Georgia, 30326, United States
Centurion Spine and Pain
Waycross, Georgia, 31501, United States
North Idaho Day Surgery
Post Falls, Idaho, 83854, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, 66215, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Michigan Pain Specialists
Ypsilanti, Michigan, 48198, United States
Weill Cornell Medical University
New York, New York, 10065, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601, United States
SC Pain and Spine Specialists
Murrells Inlet, South Carolina, 29576, United States
Precision Spine Care
Tyler, Texas, 75701, United States
Swedish Health Services
Seattle, Washington, 98122, United States
Northwest Pain Care
Spokane, Washington, 99201, United States
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia, 25301, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natalie Bloom Lyons
Boston Scientific Corporation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 10, 2019
Study Start
January 30, 2020
Primary Completion (Estimated)
February 1, 2038
Study Completion (Estimated)
February 1, 2041
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share