Superion™ IDS device
DeviceThe 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.
NCT Number: NCT04192591
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
This study is active but is not currently recruiting participants.
Notify Me45 year and older
All sexes
Interventional
Not applicable
Coastal Research Institute, LLC, Carlsbad, California, United States
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Time frame: 24-Months
Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit:
Time frame: 24-, 36-, 48- and 60-Months
Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale
Boston Scientific Corporation
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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