Phase
Condition
Spinal Stenosis
Spondylolisthesis
Treatment
Superion™ IDS device
Clinical Study ID
Ages > 45 All Genders
Study Summary
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
Study Description
Connect with a study center
Coastal Research Institute, LLC
Carlsbad, California 92009
United StatesSite Not Available
MarinHealth Spine Institute
Larkspur, California 94939
United StatesSite Not Available
Vitamed Research
Rancho Mirage, California 92270
United StatesSite Not Available
Pacific Research Institute
Santa Rosa, California 95403
United StatesSite Not Available
Boston Scientific Clinical Research
Valencia, California 91355
United StatesSite Not Available
IPM Medical Group Inc.
Walnut Creek, California 94598
United StatesSite Not Available
Holy Cross Hospital
Fort Lauderdale, Florida 33308
United StatesSite Not Available
The Orthopaedic Institute
Gainesville, Florida 32607
United StatesSite Not Available
Florida Pain Management
Sebastian, Florida 32958
United StatesSite Not Available
Alliance Spine and Pain Centers
Atlanta, Georgia 30326
United StatesSite Not Available
Centurion Spine and Pain
Waycross, Georgia 31501
United StatesSite Not Available
Axis Spine Center
Coeur d'Alene, Idaho 83815
United StatesSite Not Available
North Idaho Day Surgery
Post Falls, Idaho 83854
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Alexian Brothers Medical Center
Elk Grove Village, Illinois 60007
United StatesActive - Recruiting
Ascension Alexian Brothers
Elk Grove Village, Illinois 60007
United StatesSite Not Available
University of Kansas Hospital
Kansas City, Kansas 66160
United StatesSite Not Available
Neuroscience Research Center, LLC
Overland Park, Kansas 66215
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Forest Health Medical Center
Ypsilanti, Michigan 48198
United StatesActive - Recruiting
Michigan Pain Specialists
Ypsilanti, Michigan 48198
United StatesSite Not Available
Weill Cornell Medical University
New York, New York 10065
United StatesSite Not Available
Pacific Sports and Spine, LLC
Eugene, Oregon 97401
United StatesSite Not Available
Spinal Diagnostics
Tualatin, Oregon 97062
United StatesSite Not Available
Center for Interventional Pain and Spine
Lancaster, Pennsylvania 17601
United StatesSite Not Available
SC Pain and Spine Specialists
Murrells Inlet, South Carolina 29576
United StatesSite Not Available
Central Texas Pain Institute
Killeen, Texas 76542
United StatesSite Not Available
Precision Spine Care
Tyler, Texas 75701
United StatesSite Not Available
Swedish Health Services
Seattle, Washington 98122
United StatesSite Not Available
Northwest Pain Care
Spokane, Washington 99201
United StatesSite Not Available
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia 25301
United StatesSite Not Available
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