Postmarket Outcomes Study for Evaluation of the Superion™ Spacer (PRESS2)

  • STATUS
    Recruiting
  • End date
    Sep 27, 2026
  • participants needed
    3000
  • sponsor
    Boston Scientific Corporation
Updated on 27 October 2022

Summary

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

Description

The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.

Details
Condition Lumbar Spinal Stenosis
Treatment Superion IDS, Superion™ IDS
Clinical Study IdentifierNCT04563793
SponsorBoston Scientific Corporation
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Meets any contraindication in BSC Indirect Decompression Systems local IFU
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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