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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04192591
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To compile real-world outcomes of the Superion® IDS in routine clinical practice.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Device: Superion® IDS device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 5-year Superion® IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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.




Primary Outcome Measures :
  1. Rate of success at the 24-month follow-up visit [ Time Frame: 24-Months ]

    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


Secondary Outcome Measures :
  1. Patient Satisfaction: VertiFlex® Patient Satisfaction Survey [ Time Frame: 24-, 36-, 48- and 60-Months ]
    Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192591


Contacts
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Contact: Natalie Bloom Lyons 7632289040 ext 7632289040 lyonsn@bsci.com
Contact: Diane Keesey 661-949-4175 diane.keesey@bsci.com

Locations
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United States, California
Boston Scientific Clinical Research Recruiting
Valencia, California, United States, 91355
Contact: Boston Scientific         
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Corporation

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04192591    
Other Study ID Numbers: A4082
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Boston Scientific Corporation:
Lumbar Spinal Stenosis
LSS
Chronic Pain
Leg Pain
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases