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

Last updated: April 21, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

Superion™ IDS device

Clinical Study ID

NCT04192591
A4082
  • Ages > 45
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 consistentlyrelieved by flexion activities (example: sitting or bending over a shopping cart).

  • Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as thenarrowing of the midline sagittal spinal canal (central) and/or narrowing betweenthe 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 inEnglish.

  • Subjects, who, in the opinion of the Clinical Investigator, are able to understandthis clinical investigation, cooperate with the investigational procedures and arewilling to return for all the required post-treatment follow-ups.

  • Able to independently read and complete all questionnaires and assessments providedin English

Exclusion

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 factorsthat, in the investigator's medical judgment, might confound reporting of studyoutcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved inlitigation, workmen's compensation, spinal tumor)

  • Participating (or intends to participate) in another drug or device clinical trialthat may influence the data that will be collected for this study

Study Design

Total Participants: 214
Treatment Group(s): 1
Primary Treatment: Superion™ IDS device
Phase:
Study Start date:
January 30, 2020
Estimated Completion Date:
February 28, 2041

Study Description

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

Connect with a study center

  • Coastal Research Institute, LLC

    Carlsbad, California 92009
    United States

    Terminated

  • MarinHealth Spine Institute

    Larkspur, California 94939
    United States

    Active - Recruiting

  • Vitamed Research

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • Pacific Research Institute

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Boston Scientific Clinical Research

    Valencia, California 91355
    United States

    Site Not Available

  • IPM Medical Group Inc.

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • The Orthopaedic Institute

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Florida Pain Management

    Sebastian, Florida 32958
    United States

    Site Not Available

  • Alliance Spine and Pain Centers

    Atlanta, Georgia 30326
    United States

    Terminated

  • Centurion Spine and Pain

    Waycross, Georgia 31501
    United States

    Terminated

  • Axis Spine Center

    Coeur d'Alene, Idaho 83815
    United States

    Site Not Available

  • North Idaho Day Surgery

    Post Falls, Idaho 83854
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois 60007
    United States

    Active - Recruiting

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois 60007
    United States

    Active - Recruiting

  • University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Neuroscience Research Center, LLC

    Overland Park, Kansas 66215
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Forest Health Medical Center

    Ypsilanti, Michigan 48198
    United States

    Active - Recruiting

  • Michigan Pain Specialists

    Ypsilanti, Michigan 48198
    United States

    Terminated

  • Weill Cornell Medical University

    New York, New York 10065
    United States

    Active - Recruiting

  • Pacific Sports and Spine, LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Spinal Diagnostics

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Center for Interventional Pain and Spine

    Lancaster, Pennsylvania 17601
    United States

    Terminated

  • SC Pain and Spine Specialists

    Murrells Inlet, South Carolina 29576
    United States

    Active - Recruiting

  • Central Texas Pain Institute

    Killeen, Texas 76542
    United States

    Site Not Available

  • Precision Spine Care

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Swedish Health Services

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • Northwest Pain Care

    Spokane, Washington 99201
    United States

    Terminated

  • The Spine and Nerve Center of Saint Francis Hospital

    Charleston, West Virginia 25301
    United States

    Active - Recruiting

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