A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
Active, not recruitingNot applicableNCT04192591
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Study details
- Official title
- A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Device: Superion™ IDS device
- Sponsor
- Boston Scientific Corporation
- Start date
- 2020-01-30
- Primary completion
- 2038-02
- Sex
- All
- Age range
- from 45 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 23
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04192591