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

Boston Scientific

Status: Active, not recruiting

Conditions: Lumbar Spinal Stenosis

Treatments: Device: Superion™ IDS device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04192591

A4082

Details and patient eligibility

About

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

Full description

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

Enrollment: 166 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

Superion™ IDS device

Experimental group

Description:

Superion™ Indirect Decompression System (IDS)

Treatment:

Device: Superion™ IDS device