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STRIVE Post-Market Registry Study

Sponsored by Olympus Corporation of the Americas

About this study

This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.

This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States. Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.

Where this study is enrolling (16)

  • Dignity Health St. Joseph's Hospital and Medical Center

    Phoenix, Arizona

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  • El Camino, Taft Center for Clinical Research

    Mountain View, California

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  • University of Miami

    Coral Gables, Florida

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  • University of Chicago

    Chicago, Illinois

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  • Northwestern University, Division of Pulmonary and Critical Care Medicine

    Chicago, Illinois

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Show all 16 locations
Who can participate

Inclusion criteria

  • ✓1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
  • ✓2. Subjects must understand and voluntarily sign an informed consent form.

Exclusion criteria

  • ✕1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
  • ✕2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
  • ✕3. Subjects who have incomplete screening or baseline data.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.