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Evaluation of the Superion™ IDS device for lumbar spinal stenosis outcomes

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

Not applicable Interventional Boston Scientific Corporation · NCT04192591

This study is testing if the Superion™ device can help relieve pain in the legs, buttocks, and groin for people over 45 with lumbar spinal stenosis during everyday activities.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment214 (estimated)
Ages45 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Drugs / interventionscart
Locations27 sites (Carlsbad, California and 26 other locations)
Trial IDNCT04192591 on ClinicalTrials.gov

What this trial studies

This evaluation aims to gather real-world outcomes of the Superion™ Interspinous Decompression System (IDS) when used in routine clinical practice for patients with lumbar spinal stenosis. The study will assess the effectiveness of the device in alleviating symptoms such as leg, buttock, and groin pain, particularly in activities that require flexion. Participants will be monitored over a five-year period to determine the long-term benefits and safety of the device. The study will include patients aged 45 and older who meet specific diagnostic criteria and are able to provide informed consent.

Who should consider this trial

Good fit: Ideal candidates for this evaluation are individuals aged 45 and older with a diagnosis of degenerative lumbar spinal stenosis and persistent pain that is relieved by flexion activities.

Not a fit: Patients with conditions other than lumbar spinal stenosis or those who do not experience pain relief through flexion activities may not benefit from this evaluation.

Why it matters

Potential benefit: If successful, this evaluation could provide valuable insights into the long-term effectiveness of the Superion™ IDS device, potentially improving treatment options for patients with lumbar spinal stenosis.

How similar studies have performed: Previous studies on similar interspinous devices have shown promising outcomes, indicating potential for success in this evaluation.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Carlsbad, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lumbar Spinal StenosisLSSChronic PainLeg Pain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.