ACTIVE_NOT_RECRUITING

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

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Conditions

Lumbar Spinal StenosisLSSChronic PainLeg Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-01-30
Study Completion:2041-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04192591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 45 years of age or older when written informed consent is obtained
  2. * 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).
  3. * 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).
  4. * Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
  5. * 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.
  6. * Able to independently read and complete all questionnaires and assessments provided in English
  1. * Axial back pain only.
  2. * Fixed motor deficit in lower extremity(ies) due to LSS.
  3. * 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)
  4. * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Contacts and Locations

Principal Investigator

Natalie Bloom Lyons
STUDY_DIRECTOR
Boston Scientific Corporation

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

  • Natalie Bloom Lyons, STUDY_DIRECTOR, Boston Scientific Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-30
Study Completion Date2041-02

Study Record Updates

Study Start Date2020-01-30
Study Completion Date2041-02

Terms related to this study

Keywords Provided by Researchers

  • Lumbar Spinal Stenosis
  • LSS
  • Chronic Pain
  • Leg Pain

Additional Relevant MeSH Terms

  • Lumbar Spinal Stenosis