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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Superion™ IDS device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Research Institute, LLC
    • Larkspur, California, United States, 94939
      • MarinHealth Spine Institute
    • Rancho Mirage, California, United States, 92270
      • Vitamed Research
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group Inc.
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Gainesville, Florida, United States, 32607
      • The Orthopaedic Institute
  • Georgia
    • Atlanta, Georgia, United States, 30326
      • Alliance Spine and Pain Centers
    • Waycross, Georgia, United States, 31501
      • Centurion Spine and Pain
  • Idaho
    • Post Falls, Idaho, United States, 83854
      • North Idaho Day Surgery
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • Ascension Alexian Brothers
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
    • Overland Park, Kansas, United States, 66215
      • Neuroscience Research Center, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Ypsilanti, Michigan, United States, 48198
      • Michigan Pain Specialists
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical University
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports and Spine, LLC
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Center for Interventional Pain and Spine
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • SC Pain and Spine Specialists
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Health Services
    • Spokane, Washington, United States, 99201
      • Northwest Pain Care
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Spine and Nerve Center of Saint Francis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superion™ IDS device; Superion™ Indirect Decompression System (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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 complicationsno dislodgement, migration, or device deformationno 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction: VertiFlex® Patient Satisfaction Survey	Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale	24-, 36-, 48- and 60-Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Publications and helpful links

Helpful Links

• The SCOPE Study for Spinal Stenosis (vertiflexstudy.com)

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Estimated): February 1, 2038
• Study Completion (Estimated): February 1, 2041

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Lumbar Spinal Stenosis; LSS; Leg Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Spinal Stenosis
• Other Study ID Numbers: A4082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes