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

Purpose

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

Condition

  • Lumbar Spinal Stenosis

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Kansas Hospital
Kansas City, Kansas 66160
Contact:
Boston Scientific Clinical Research
855-213-9890
BSNClinicalTrials@bsci.com

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Ann Yamano
855-213-9890
BSNClinicalTrials@bsci.com

Detailed Description

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