N/A
Completed N=129
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Source: ClinicalTrials.gov NCT04563793 ↗Enrolled (actual)
129
Serious AEs
9.3%
Results posted
Jan 2025
Primary outcomePrimary: Low Back Pain Responder Rate — 17; 3; 1; 2 Participants
Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Back Pain Responder Rate |
17; 3; 1; 2 | — |
| PRIMARY Left Leg Pain Responder Rate |
15; 7; 2; 0 | — |
| PRIMARY Right Leg Pain Responder Rate |
18; 6; 3; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
- Signed a valid, IRB approved informed consent form
Key Exclusion Criteria
- Meets any contraindication in BSC Indirect Decompression Systems local IFU
Data sourced from ClinicalTrials.gov (NCT04563793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.